Analytical and Bioanalytical Methods for the Quantification of the Nucleotide
Polymerase Inhibitor - Sofosbuvir: A Critical Review (2015-2021)

Shilpi      Pathak; Muskan      Bhardwaj; Ramreddy      Godela
doi:10.2174/1573412918666221011112422
Abstract

Sofosbuvir is a regularly used antiviral medication that was approved for clinical usage in hepatitis C patients. Sofosbuvir belongs to the nucleotide analog drug class, and it operates by inhibiting hepatitis C NS5B protein. This study focuses on the many analytical methods for detecting and quantifying Sofosbuvir in pharmaceutical formulations, biological samples, and fixed dosage combinations. Chromatographic techniques, electro-analytical methods, chemometric procedures, and optical approaches are just a few of the approaches mentioned in the literature. The most often used methods for the analysis of Sofosbuvir are HPLC-based methods with UV/Vis spectrophotometric, fluorescence, and mass spectrometric detection. This article could be extremely useful in creating upcoming Sofosbuvir analytical approaches or investigations.
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Graphical Abstract

[1]
Fralick, M.; Feld, J.J.; Hepatitis, C. Hepatitis C virus infection. CMAJ,  2015, 187(15), 1159.
 [http://dx.doi.org/10.1503/cmaj.140290] [PMID:  26303246]

[2]
Marcellin, P.; Hepatitis, C.; Hepatitis, C. The clinical spectrum of the disease. J. Hepatol.,  1999, 31(Suppl. 1), 9-16.
 [http://dx.doi.org/10.1016/S0168-8278(99)80368-7] [PMID:  10622554]

[3]
Stedman, C. Sofosbuvir, a NS5B polymerase inhibitor in the treatment of hepatitis C: A review of its clinical potential. Therap. Adv. Gastroenterol.,  2014, 7(3), 131-140.
 [http://dx.doi.org/10.1177/1756283X13515825] [PMID:  24790644]

[4]
Lawitz, E.; Jacobson, I.M.; Nelson, D.R.; Zeuzem, S.; Sulkowski, M.S.; Esteban, R.; Brainard, D.; McNally, J.; Symonds, W.T.; McHutchison, J.G.; Dieterich, D.; Gane, E. Development of sofosbuvir for the treatment of hepatitis C virus infection. Ann. N. Y. Acad. Sci.,  2015, 1358(1), 56-67.
 [http://dx.doi.org/10.1111/nyas.12832] [PMID:  26235748]

[5]
Lawitz, E.; Mangia, A.; Wyles, D.; Rodriguez-Torres, M.; Hassanein, T.; Gordon, S.C.; Schultz, M.; Davis, M.N.; Kayali, Z.; Reddy, K.R.; Jacobson, I.M.; Kowdley, K.V.; Nyberg, L.; Subramanian, G.M.; Hyland, R.H.; Arterburn, S.; Jiang, D.; McNally, J.; Brainard, D.; Symonds, W.T.; McHutchison, J.G.; Sheikh, A.M.; Younossi, Z.; Gane, E.J.; Symonds, W.T.; Pharm, D.; Mchutchison, J.G.; Sheikh, A.M. Sofosbuvir for previously untreated chronic hepatitis C infection. N. Engl. J. Med.,  2013, 368(20), 1878-1887.
 [http://dx.doi.org/10.1056/NEJMoa1214853] [PMID:  23607594]

[6]
Kilic, A.; Beyazsakal, L.; Findik, B.T.; Incebay, H. Synthesis and electrochemical investigation of chiral amine bis(phenolate)-boron complexes: In vitro antibacterial activity screening of boron compounds. Inorg. Chim. Acta,  2020, 510, 119777.

[7]
Kilic, A.; Savci, A.; Alan, Y.; Birsen, H. Synthesis and spectroscopic properties of 4,4-bipyridine linker bioactive macrocycle boronate esters: Photophysical properties and antimicrobial with antioxidant studies. J. Organomet. Chem.,  2021, 941, 121807.
 [http://dx.doi.org/10.1016/j.jorganchem.2021.121807]

[8]
Tülüce, Y.; Masseh, H.D.I. Koyuncu, İ.; Kiliç, A.; Durgun, M.; Özkol, H. Novel fluorine boron hybrid complex as potential antiproliferative drugs on colorectal cancer cell line. Anticancer. Agents Med. Chem.,  2019, 19(5), 627-637.
 [http://dx.doi.org/10.2174/1871520619666190117142353] [PMID:  30652651]

[9]
Kilic, A.; Söylemez, R. Okumuş V. Design, spectroscopic properties and effects of novel catechol spiroborates derived from Schiff bases in the antioxidant, antibacterial and DNA binding activity. J. Organomet. Chem.,  2022, 960, 122228.
 [http://dx.doi.org/10.1016/j.jorganchem.2021.122228]

[10]
Lee, P.N.; Fry, J.S.; Forey, B.A. A review of the evidence on smoking bans and incidence of heart disease. Regul. Toxicol. Pharmacol.,  2014, 70(1), 7-23.
 [http://dx.doi.org/10.1016/j.yrtph.2014.06.014] [PMID:  24956588]

[11]
Tülüce, Y.; Lak, P.T.A. Koyuncu, İ. Kılıç, A.; Durgun, M.; Özkol, H. The apoptotic, cytotoxic and genotoxic effect of novel binuclear boron-fluoride complex on endometrial cancer. Biometals,  2017, 30(6), 933-944.
 [http://dx.doi.org/10.1007/s10534-017-0060-8] [PMID:  29052084]

[12]
Hassouna, M.E.M.; Mohamed, M.A. UV-Spectrophotometric and stability indicating RP-HPLC methods for the determination of the hepatitis c virus inhibitor sofosbuvir in tablet dosage form. Anal. Chem. Lett.,  2018, 8(2), 217-229.
 [http://dx.doi.org/10.1080/22297928.2017.1410441]

[13]
Hamd, M.A.E.; Ali, R.; Marzouk, A.A.; Abdelmageed, O.H. Validated ultraviolet-spectrometric method for determination of sofosbuvir in tablets formulation. J. Appl. Pharm. Sci.,  2017, 7, 114-119.

[14]
Nithya, P.D. Babu, Govada Kishore; Pallavi, K.; Rao, G.E.; Babu,  P.S. Development and validation of UV- visible spectrophotometric  method for development and validation of uv- visible spectrophotometric  method for the determination of sofosbuvir. Indian  Pharm., 2017. 14, 08

[15]
Abdel-Gawad, S.A.N. Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms. Eur. J. Chem.,  2016, 7(3), 375-379.
 [http://dx.doi.org/10.5155/eurjchem.7.3.375-379.1439]

[16]
Omprakash, B.G.; Vivek, M.G.; Sachin, G.B.; Madhuri, P.V. Kumar, Maurya Development, validation and stability study of uv spectrophotometric method for determination of sofosbuvir in bulk and pharmaceutical dosage forms. J. Pharm. Res.,  2017, 11, 847-849.

[17]
Baker, M.M.; El-Kafrawy, D.S.; Mahrous, M.S.; Belal, T.S. Validated spectrophotometric and chromatographic methods for analysis of the recently approved hepatitis C antiviral combination ledipasvir and sofosbuvir. Ann. Pharm. Fr.,  2018, 76(1), 16-31.
 [http://dx.doi.org/10.1016/j.pharma.2017.07.005] [PMID:  28842163]

[18]
Kishore, M.S.; Rambabu, C. Development and validation of UV Spectrophotometric method for the estimation of Sofosbuvir and Ledipasvir in combined Pharmaceutical dosage forms. Int. J. Chemtech Res.,  2019, 12(3), 33-40.
 [http://dx.doi.org/10.20902/IJCTR.2019.120305]

[19]
Eissa, M.S. Simultaneous determination of the brand new two-drug combination for the treatment of hepatitis C: Sofosbuvir/ledipasvir using smart spectrophotometric methods manipulating ratio spectra. Spectrochim. Acta A Mol. Biomol. Spectrosc.,  2017, 183, 362-370.
 [http://dx.doi.org/10.1016/j.saa.2017.04.052] [PMID:  28460317]

[20]
Mansour, F.R. A new innovative spectrophotometric method for the simultaneous determination of sofosbuvir and ledipasvir. Spectrochim. Acta A Mol. Biomol. Spectrosc.,  2018, 188, 626-632.
 [http://dx.doi.org/10.1016/j.saa.2017.07.066] [PMID:  28783604]

[21]
Abdelhalim, A. Stability-Indicating HPLC and UV Spectrophotometric Determination of Sofosbuvir in Pure Form and Tablets. Al-Azhar. J. Pharm. Sci.,  2015, 52, 233-247.

[22]
Rai, S.Y.; Prajapati, Y.; Patni, P. Development and validation of RP-HPLC and UV spectroscopy methods for simultaneous estimation of sofosbuvir and ledipasvir in their combined tablet dosage form. Pharma Sci. Monitor,  2017, 8, 369-388.

[23]
Kamal, A.H.; Mabrouk, M.M.; Bebawy, L.I.; Mekky, M.A. Spectrophotometric and robust UPLC methods for simultaneous determination of velpatasvir and sofosbuvir in their tablet. Microchem. J.,  2019, 149, 103996.
 [http://dx.doi.org/10.1016/j.microc.2019.103996]

[24]
Rezk, M.R.; Monir, H.H.; Marzouk, H.M. Spectrophotometric assessment of the brand new antiviral combination: Sofosbuvir and velpatasvir in their pure forms and pharmaceutical formulation. Spectrochim. Acta A Mol. Biomol. Spectrosc.,  2019, 213, 159-166.
 [http://dx.doi.org/10.1016/j.saa.2019.01.058] [PMID:  30685554]

[25]
El-Gamal, R.M.; Abdel-Gawad, S.A.; Belal, F.F.; Moustapha, M.E. Selective and sensitive spectrofluorimetric quantification of velpatasvir in presence of sofosbuvir. Application to their co-formulated tablet. RSC Advances,  2018, 8(57), 32909-32915.
 [http://dx.doi.org/10.1039/C8RA06588H] [PMID:  35547725]

[26]
Abdel-Lateef, M.A.; Ali, R.; Omar, M.A.; Derayea, S.M. Micellar based spectrofluorimetric method for the selective determination of ledipasvir in the presence of sofosbuvir: Application to dosage forms and human plasma. Luminescence,  2020, 35(4), 486-492.
 [http://dx.doi.org/10.1002/bio.3753] [PMID:  31869004]

[27]
Kumar, M.; Jindal, M.; Bhatt, S.; Pandurangan, A.; Malik, A.; Kaushik, V.; Kumar, P. Simultaneous estimation of amlodipine besylate and ramipril in tablets dosage form by UV spectrophotometric method. J. Pharm. Sci. Res.,  2019, 11, 667-670.

[28]
Agrawal, G.P. Validated stability indicating method for determination of indapamide in pharmaceutical formulation. Research Journal of Pharmacy and Technology,  2021, 14, 3347-3352.
 [http://dx.doi.org/10.52711/0974-360X.2021.00582]

[29]
Garg, A.; Agrawal, G.P. S, K. Development and validation of reversed phase HPLC-PDA method for the quantification of chrysin in solid lipid nanoparticles. Int. J. Appl. Pharm.,  2019, 11, 324-328.

[30]
Singh, K.; Bhatt, S.; Prasad, R. HPLC method for estimation of drug release of sofosbuvir in pharmaceutical formulation. Int. J. Pharm. Sci. Res.,  2019, 10, 367-372.

[31]
El-Yazbi, A.F.; Elashkar, N.E.; Abdel-Hay, K.M.; Talaat, W.; Ahmed, H.M. Eco-friendly HPTLC method for simultaneous analysis of sofosbuvir and ledipasvir in biological and pharmaceutical samples: Stability indicating study. Microchem. J.,  2020, 154, 104584.
 [http://dx.doi.org/10.1016/j.microc.2019.104584]

[32]
Ravisankar, P.; Sivaparvathi, Y.; Sri, K.C.; Ameen, S.A.; Kiranmai, D.; Ram, R.S.; Kumar, J.P.; Sulthana, S. Development and validation of Rapid RP- HPLC method for the determination of paroxetine in bulk and pharmaceutical dosage form. Pharm. Lett.,  2016, 8, 43-52.

[33]
Shaikh, S.N.; Manjushri, P. Development and validation of RP-HPLC method for quantitative analysis of sofosbuvir in pure and pharmaceutical formulation. World J. Pharm. Pharm. Sci.,  2017, 6, 2249-2258.
 [http://dx.doi.org/10.20959/wjpps20178-9909]

[34]
Hamdache, A.; Grib, L.; Grib, C.; Adour, L.; Zatout, H.; Mezrouai, A.; Saraoui, S. Forced degradation studies of sofosbuvir with a developed and validated RP-HPLC method as per ICH guidelines. Chromatographia,  2021, 84(12), 1131-1140.
 [http://dx.doi.org/10.1007/s10337-021-04099-8]

[35]
Ganji, S.; Dhulipala, S.; Nemala, A.R. Development and validation of RP HPLC method for the estimation of Sofosbuvir and related impurity in bulk and pharmaceutical dosage form. Future Journal of Pharmaceutical Sciences,  2021, 7(1), 154.
 [http://dx.doi.org/10.1186/s43094-021-00285-5]

[36]
Chinababu, D. A novel stress indicating RP-HPLC method development and validation for the simultaneous estimation of velpatasvir and sofosbuvir in bulk and its tablet dosage form. J. Pharm. Res. Int.,  2019, 26, 1-10.
 [http://dx.doi.org/10.9734/jpri/2019/v26i230135]

[37]
Hanuman, T.; Sivakkumar, T.; Sridhar, S. New analytical method development and validation for simultaneous estimation of sofosbuvir and velpatasvir in bulk and pharmaceutical dosage form by RP-HPLC method. J. Drug Deliv. Ther.,  2020, 10(5), 143-148.
 [http://dx.doi.org/10.22270/jddt.v10i5.4296]

[38]
Saroja, J.; Anantha Lakshmi, P.V.; Rammohan, Y.; Divya, D.; Santhosh Kumar, P. Concurrent estimation of sofosbuvir and velpatasvir in raw and tablets using stability indicating RP-HPLC method. Rasayan J. Chem.,  2018, 11(3), 1058-1066.
 [http://dx.doi.org/10.31788/RJC.2018.1132010]

[39]
Bandla, J.; Ganapaty, S. Stability indicating RP-HPLC method development and validation for the simultaneous determination of Sofosbuvir and Velpatasvir in tablet dosage forms. Indian Journal of Pharmaceutical and Biological Research,  2017, 5(4), 10-16.
 [http://dx.doi.org/10.30750/ijpbr.5.4.3]

[40]
Sreehitha, V.; Sireesha, R.; Sivagami, B.; Pavan, K.V.; Chandrasekar, R.; Babu, M.N. Simultaneous estimation of sofosbuvir and velpatasvir tablets by RP- HPLC Method. Int. J. Res. Dev. Pharm. Life Sci.,  2018, 7, 3092-3099.

[41]
Priyanka, K.; Vinutha, K.; Sridevi, P.; Ramya, B.; Bhagavan Raju, M. A stability indicating RP-HPLC method for simultaneous estimation of velpatasvir and sofosbuvir in its bulk and tablet dosage form. American Journal of PharmTech Research,  2018, 8(2), 129-139.
 [http://dx.doi.org/10.46624/ajptr.2018.v8.i2.009]

[42]
Sandya Rani, J.; Devanna, N. Development and validation of RP-HPLC method for the simultaneous estimation of sofosbuvir, velpatasvir and voxilaprevir in bulk and tablet dosage forms. Rasayan J. Chem.,  2018, 11(2), 452-459.
 [http://dx.doi.org/10.31788/RJC.2018.1122079]

[43]
Mamatha, J.; Devanna, N. Simultaneous RP-HPLC method development and it’s validation for estimation of sofosbuvir and velpatasvir in their combined dosage form. Rasayan J. Chem.,  2018, 11, 392-400.

[44]
Mastanamma, S.K.; Chandini, S.K.; Reehana, S.K.; Saidulu, P. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Sofosbuvir and Ledipasvir in bulk and their combined dosage form. Future Journal of Pharmaceutical Sciences,  2018, 4(2), 116-123.
 [http://dx.doi.org/10.1016/j.fjps.2017.11.003]

[45]
Hemdan, A.; Eissa, M.S. Simultaneous chromatographic analysis of Sofosbuvir/Ledipasvir in their combined dosage form: An application to green analytical chemistry. J. Anal. Sci. Technol.,  2019, 10(1), 39.
 [http://dx.doi.org/10.1186/s40543-019-0197-x]

[46]
Swathi, K.; Rao, P.V.; Srinivasa Rao, N. A new analytical method for determination of dolutegravir and rilpivirine in pharmaceutical formulations by RP-HPLC method. Int. J. Res. Pharm. Chem. Anal.,  2019, 1, 59-67.

[47]
Baker, M.M.; Hammad, S.F.; Belal, T.S. Development and validation of a versatile HPLC-DAD method for simultaneous determination of the antiviral drugs daclatasvir, ledipasvir, sofosbuvir and ribavirin in presence of seven potential impurities. Application to assay of dosage forms and dissolution studies. Drug Dev. Ind. Pharm.,  2019, 45(7), 1111-1119.
 [http://dx.doi.org/10.1080/03639045.2019.1593444] [PMID:  30929537]

[48]
Balaswami, B.; Ramana, P.V.; Rao, B.S.; Sanjeeva, P. A new simple stability-indicating RP-HPLC-PDA method for simultaneous estimation of triplicate mixture of sofosbuvir, velpatasvir and voxilaprevir in tablet dosage form. Research Journal of Pharmacy and Technology,  2018, 11(9), 4147.
 [http://dx.doi.org/10.5958/0974-360X.2018.00762.X]

[49]
Ezzeldin, E.; Abo-Talib, N.F.; Tammam, M.H.; Asiri, Y.A.; Amr, A.E.G.E.; Almehizia, A.A. Validated reversed-phase liquid chromatographic method with gradient elution for simultaneous determination of the antiviral agents: Sofosbuvir, ledipasvir, daclatasvir, and simeprevir in their dosage forms. Molecules,  2020, 25(20), 4611.
 [http://dx.doi.org/10.3390/molecules25204611] [PMID:  33050433]

[50]
Atia, N.N.; El-Shaboury, S.R.; El-Gizawy, S.M.; Abo-Zeid, M.N. Simultaneous quantitation of two direct acting hepatitis C antivirals (sofosbuvir and daclatasvir) by an HPLC-UV method designated for their pharmacokinetic study in rabbits. J. Pharm. Biomed. Anal.,  2018, 158, 88-93.
 [http://dx.doi.org/10.1016/j.jpba.2018.05.028] [PMID:  29864695]

[51]
Fares, M.Y.; Abdelwahab, N.S.; Abdelrahman, M.M.; Abdel-Rahman, H.M. Determination of sofosbuvir with two co-administered drugs; paracetamol and DL-methionine by two chromatographic methods. Application to a pharmacokinetic study. Bioanalysis,  2019, 11(5), 349-364.
 [http://dx.doi.org/10.4155/bio-2018-0191] [PMID:  30873855]

[52]
Farid, N.F.; Abdelwahab, N.S. Chromatographic analysis of ledipasvir and sofosbuvir: New treatment for chronic hepatitis C infection with application to human plasma. J. Liq. Chromatogr. Relat. Technol.,  2017, 40(7), 327-332.
 [http://dx.doi.org/10.1080/10826076.2017.1298526]

[53]
Miraghaei, S.; Mohammadi, B.; Babaei, A.; Keshavarz, S.; Bahrami, G. Development and validation of a new HPLC-DAD method for quantification of sofosbuvir in human serum and its comparison with LC–MS/MS technique: Application to a bioequivalence study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2017, 1063, 118-122.
 [http://dx.doi.org/10.1016/j.jchromb.2017.06.047] [PMID:  28858753]

[54]
Mehmood, Y.; Khan, I.U.; Shahzad, Y.; Khalid, S.H.; Irfan, M.; Asghar, S.; Yousaf, A.M.; Hussain, T.; Khalid, I. Development and validation of a stability-Indicating RP-HPLC method for simultaneous estimation of sofosbuvir and velpatasvir in fixed dose combination tablets and plasma. Pak. J. Pharm. Sci.,  2019, 32(4)(Suppl.), 1835-1842.
 [PMID:  31680080]

[55]
Rathod, R.U.; Navyasree, K.S.; Bhat, K. Quantification of sofosbuvir in human plasma: RP-HPLC method development and validation. Pharm. Chem. J.,  2018, 52(7), 663-673.
 [http://dx.doi.org/10.1007/s11094-018-1878-2]

[56]
Youssef, A.A.; Magdy, N.; Hussein, L.A.; El-Kosasy, A.M. Validated RP-HPLC method for simultaneous determination of ribavirin, sofosbuvir and daclatasvir in human plasma: A treatment protocol administered to HCV patients in Egypt. J. Chromatogr. Sci.,  2019, 57(7), 636-643.
 [http://dx.doi.org/10.1093/chromsci/bmz038] [PMID:  31063182]

[57]
Zidan, D.W.; Hassan, W.S.; Elmasry, M.S.; Shalaby, A.A. Investigation of anti-Hepatitis C virus, sofosbuvir and daclatasvir, in pure form, human plasma and human urine using micellar monolithic HPLC-UV method and application to pharmacokinetic study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2018, 1086, 73-81.
 [http://dx.doi.org/10.1016/j.jchromb.2018.04.011] [PMID:  29660665]

[58]
Lalitha, K.V.; Raveendra Reddy, J.; Devanna, N. Stability indicating RP-HPLC method development and validation for estimation of sofosbuvir in pharmaceutical dosage form. Pharma Innov. J.,  2018, 7, 656-662.

[59]
Ghante, M.R.; Sawant, S.D.; Shinde, A.; Bhusari, V.K. Development and validation of stability indicating Hptlc method for the estimation of sofosbuvir. Int. J. Pharm. Sci. Res.,  2021, 12, 2656-2661.

[60]
Abdel-Razeq, S.A.; Nasr, Z.A.; Said, S. Validated stability – indicating methods for determination of sofosbuvir by UPLC and HPTLC in pure form and tablet dosage forms. Asian J. Appl. Chem. Res.,  2019, 3, 1-13.
 [http://dx.doi.org/10.9734/ajacr/2019/v3i430097]

[61]
Damle, M.C.; Kalaskar, P.B. Stability indicating HPTLC method for sofosbuvir and velpatasvir in combination. Int. J. Pharm. Sci. Drug Res.,  2020, 12, 129-135.
 [http://dx.doi.org/10.25004/IJPSDR.2020.120206]

[62]
Abo-Zeid, M.N.; El-Gizawy, S.M.; Atia, N.N.; El-Shaboury, S.R. Efficient HPTLC-dual wavelength spectrodensitometric method for simultaneous determination of sofosbuvir and daclatasvir: Biological and pharmaceutical analysis. J. Pharm. Biomed. Anal.,  2018, 156, 358-365.
 [http://dx.doi.org/10.1016/j.jpba.2018.04.049] [PMID:  29753282]

[63]
Suganthia, A.; Satheshkumara, S.; Ravi, T.K. Development of validated specific stability-indicating HPTLC method for the simultaneous determination of ledipasvir and sofosbuvir in fixed dose tablet formulation. Asian J. Nanosci. Mater.,  2019, 2, 228-243.

[64]
El-Gizawy, S.M.; El-Shaboury, S.R.; Atia, N.N.; Abo-Zeid, M.N. New, simple and sensitive HPTLC method for simultaneous determination of anti-hepatitis C sofosbuvir and ledipasvir in rabbit plasma. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2018, 1092, 432-439.
 [http://dx.doi.org/10.1016/j.jchromb.2018.06.033] [PMID:  29945107]

[65]
Agrawal, G.P.; Maheshwari, R.K.; Mishra, P. Validation of ultra performance liquid chromatography-tandem mass spectrometry coupled with electrospray ionization method for quantitative determination of ornidazole in solid dispersion. Curr. Pharm. Anal.,  2020, 16(5), 487-493.
 [http://dx.doi.org/10.2174/1573412914666181024145937]

[66]
Nebsen, M.; Elzanfaly, E.S. Stability-indicating method and LC–MS-MS characterization of forced degradation products of sofosbuvir. J. Chromatogr. Sci.,  2016, 54(9), 1631-1640.
 [http://dx.doi.org/10.1093/chromsci/bmw119] [PMID:  27436268]

[67]
Elkady, E.F.; Aboelwafa, A.A. A rapid and optimized LC-MS/MS method for the simultaneous extraction and determination of sofosbuvir and ledipasvir in human plasma. J. AOAC Int.,  2016, 99(5), 1252-1259.
 [http://dx.doi.org/10.5740/jaoacint.16-0021] [PMID:  27480956]

[68]
Abdallah, O.M.; Abdel-Megied, A.M.; Gouda, A.S. Development and validation of LC-MS/MS method for simultaneous determination of sofosbuvir and daclatasvir in human Plasma: Application to pharmacokinetic study. Biomed. Chromatogr.,  2018, 32(6), e4186.
 [http://dx.doi.org/10.1002/bmc.4186] [PMID:  29314090]

[69]
Hefnawy, M.; Hammad, S.; Kadi, A.; Alsaif, N.; Mohammed, M.; Al-Hossaini, A.; Bin Jardan, Y.; Attwa, M.; Abou-El-Alamin, M. Effective quantification of ravidasvir (an NS5A inhibitor) and sofosbuvir in rat plasma by validated LC-MS/MS method and its application to pharmacokinetic study. Arab. J. Chem.,  2020, 13(11), 8160-8171.
 [http://dx.doi.org/10.1016/j.arabjc.2020.09.048]

[70]
Konam, K.; Reddy, S. Quantification of sofosbuvir and velpatasvir in human plasma using LCMS/MS technique -application to pharmacokinetic study. J. Young Pharm.,  2019, 11(3), 266-273.
 [http://dx.doi.org/10.5530/jyp.2019.11.54]

[71]
Elkady, E.F.; Aboelwafa, A.A. Rapid bioanalytical LC-MS/MS method for the simultaneous determination of sofosbuvir and velpatasvir in human plasma-application to a pharmacokinetic study in Egyptian volunteers. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2018, 1102-1103, 116-124.
 [http://dx.doi.org/10.1016/j.jchromb.2018.10.020] [PMID:  30384188]

[72]
Evangelin, M.P.; Babu, S.M.; Kumar, K.R.; Sunitha, P. UPLC method development and validation for simultaneous estimation of sofosbuvir and ledipasvir in tablet dosage form. World J. Pharm. Res.,  2018, 4, 225-229.

[73]
van Seyen, M.; de Graaff Teulen, M.J.A.; van Erp, N.P.; Burger, D.M. Quantification of second generation direct-acting antivirals daclatasvir, elbasvir, grazoprevir, ledipasvir, simeprevir, sofosbuvir and velpatasvir in human plasma by UPLC-MS/MS. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2019, 1110-1111, 15-24.
 [http://dx.doi.org/10.1016/j.jchromb.2019.01.024] [PMID:  30776611]

[74]
Pan, C.; Chen, Y.; Chen, W.; Zhou, G.; Jin, L.; Zheng, Y.; Lin, W.; Pan, Z. Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MS and its application to a pharmacokinetic study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2016, 1008, 255-259.
 [http://dx.doi.org/10.1016/j.jchromb.2015.11.056] [PMID:  26684720]

[75]
Shi, X.; Zhu, D.; Lou, J.; Zhu, B.; Hu, A.; Gan, D. Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MS. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2015, 1002, 353-357.
 [http://dx.doi.org/10.1016/j.jchromb.2015.08.038] [PMID:  26363369]

[76]
Rezk, M.R.; Basalious, E.B.; Amin, M.E. Novel and sensitive UPLC-MS/MS method for quantification of sofosbuvir in human plasma: Application to a bioequivalence study. Biomed. Chromatogr.,  2016, 30(9), 1354-1362.
 [http://dx.doi.org/10.1002/bmc.3690] [PMID:  26821881]

[77]
Singhala, R.; Tiwaria, P.; Dusejab, A.; Ramachandranc, R.; Patiald, A.; Attrid, S. Quantification of plasma levels of antiviral drug sofosbuvir and its metabolite GS331007 in patients of chronic hepatitis C with chronic kidney disease using UPLC-MS/MS method. Asian Journal of Pharmaceutical Research and Development,  2020, 8(1), 59-66.
 [http://dx.doi.org/10.22270/ajprd.v8i1.659]

[78]
Attia, K.A.M.; El-Abasawi, N.M.; El-Olemy, A.; Abdelazim, A.H. Application of different analytical techniques for determination of velpatsvir and sofosbuvir in the pharmaceutical preparation. J. Liq. Chromatogr. Relat. Technol.,  2018, 41(9), 467-473.
 [http://dx.doi.org/10.1080/10826076.2018.1462203]
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DOI https://dx.doi.org/10.2174/1573412918666221011112422	Print ISSN 1573-4129
Publisher Name Bentham Science Publisher	Online ISSN 1875-676X
Current Pharmaceutical Analysis

Analytical and Bioanalytical Methods for the Quantification of the Nucleotide Polymerase Inhibitor - Sofosbuvir: A Critical Review (2015-2021)

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