Generic placeholder image

Anti-Infective Agents

Editor-in-Chief

ISSN (Print): 2211-3525
ISSN (Online): 2211-3533

Retraction Notice

Retracted: Analytical Method Development and Validation for Determination of Assay of Antibacterial Drugs Besifloxacin Hydrochloride and Phenoxyethanol in Gel Formulation

Author(s): Pradeep Kundu, Neelam Pawar*, Neha Minocha and Asha Poonia

Volume 21, Issue 4, 2023

Published on: 09 June, 2023

Article ID: e310323215342 Pages: 18

DOI: 10.2174/2211352521666230331111623

Price: $65

Abstract

The article entitled “Analytical Method Development and Validation for Determination of Assay of Antibacterial Drugs Besifloxacin Hydrochloride and Phenoxyethanol in Gel Formulation”, by Pradeep Kundu, Neelam Pawar, Neha Minocha and Asha Poonia, published in Anti-Infective Agents 2023; 21(4): e310323215342. https://dx.doi.org/10.2174/2211352521666230331111623.

The corresponding author of this article submitted it simultaneously to the journal “Biochemistry & Analytical Biochemistry of Walsh Medical Media publishers and to the journal of “Anti-Infective Agents” of Bentham Science Publishers. Therefore, the article has been retracted due to the unethical practice of the author and during plagiarism checking with a previously published article titled: “Analytical Method Development and Validation for the Determination of Assay of Antibacterial Drugs Besifloxacin Hydrochloride and Phenoxyethanol in Gel Formulation. Biochem Anal Biochem. 11:426. doi: 10.35248/2161-1009.22.11.426 The authors were informed of this submission and were suggested to give justification on the matter in their defense. Instead of sending justification, the corresponding author Dr. Neelam Pawar suggested Bentham Science Publishers to retract this article.

Bentham Science apologizes to the readers of the journal for any inconvenience this may have caused. The Editorial Policy of Bentham Science Publishers on Article Retraction can be found at the link https://benthamscience.com/editorial-policies-main.php.

BENTHAM SCIENCE DISCLAIMER: It is a condition of publication that manuscripts submitted to this journal have not been published and will not be simultaneously submitted or published elsewhere. Furthermore, any data, illustration, structure or table that has been published elsewhere must be reported, and copyright permission for reproduction must be obtained. Plagiarism is strictly forbidden, and by submitting the article for publication, the authors agree that the publishers have the legal right to take appropriate action against the authors if plagiarism or fabricated information is discovered. By submitting a manuscript, the authors agree that the copyright of their article is transferred to the publishers if and when the article is accepted for publication.

Erratum For:
Analytical Method Development and Validation for Determination of Assay of Antibacterial Drugs Besifloxacin Hydrochloride and Phenoxyethanol in Gel Formulation

[1]
Sankar, R.S. Text Book of Pharmaceutical Analysis, 3rd ed; Rx Publications, 2001, pp. 18-15.
[2]
Bhati, C.; Minocha, N.; Purohit, D.; Kumar, S.; Makhija, M.; Saini, S.; Kaushik, D.; Pandey, P. High performance liquid chromatography: recent patents and advancement. Biomed. Pharmacol. J., 2022, 15(2), 729-746.
[http://dx.doi.org/10.13005/bpj/2411]
[3]
Kumar, V.; Minocha, N.; Garg, V.; Dureja, H. Nanostructured materials used in drug delivery. Mater. Today Proc., 2022, 69, 174-180.
[http://dx.doi.org/10.1016/j.matpr.2022.08.306]
[4]
Minocha, N.; Saini, S.; Pandey, P. Design of experiments: how to develop and optimize drug delivery systems. TMR Pharmacol. Res., 2022, 2(3), 10.
[http://dx.doi.org/10.53388/PR202202010]
[5]
Hotha, K.K.; Reddy, S.P.K.; Raju, V.K.; Ravindranath, L.K. Forced degradation studies practical approach -overview of regulatory guidance and literature for the drug products and drug substances. Int. Res. J. Pharm., 2013, 4(5), 78-85.
[http://dx.doi.org/10.7897/2230-8407.04517]
[6]
Narendra, M.V.; Talluri, K. Quality by design- Regulatory considerations for pharmaceutical analytical methods. Pharm. Regul. Aff., 2014, 103, 3:3.
[7]
Ravichandran, V.; Shalini, S.; Harish, K.M. Validation of Analytical methods– strategies & importance. Int. J. Pharm. Pharm. Sci., 2010, 2(3), 18-22.
[8]
Ravisankar, P.; Navya, C.N.; Pravallika, D. A review on step-by-step analytical method validation. IOSR J. Pharm., 2015, 5(10), 7-19.
[9]
Gupta, V.; Jain, A.D.K.; Gill, N.S. Development and validation of HPLC method - A review. Int. Res. J. Pharm. Appl. Sci., 2012, 2(4), 17-25.
[10]
Saimalakondaiah, D.; Kumar, V.R.; Reddy, T.R.M. Stability indicating HPLC method development and validation. Int. J. Pharma Res. Rev., 2014, 3(10), 46-57.
[11]
Marson, B.; Concentino, V.; Junkert, A.; Fachi, M.; Vilhena, R.; Pontarolo, R. Validation of analytical methods in a pharmaceutical quality system: An overview focused on HPLC methods. Quim. Nova, 2020, 43, 1190-1203.
[http://dx.doi.org/10.21577/0100-4042.20170589]
[12]
National Center for Biotechnology Information. PubChem Compound Summary for CID 31236, 2-Phenoxyethanol. 2023. Available From: https://pubchem.ncbi.nlm.nih.gov/compound/2-Phenoxy
[13]
Attimarad, M.; Venugopala, K.N. SreeHarsha, N.; Aldhubiab, B.E.; Nair, A.B. Validation of rapid RP-HPLC method for concurrent quantification of amlodipine and celecoxib in pure and formulation using an experimental design. Microchem. J., 2020, 152, 104365.
[http://dx.doi.org/10.1016/j.microc.2019.104365]
[14]
Sharma, B.; Singh, L.R. Pharmaceutical gels for topical drug delivery: An overview. Int. J. Pharm. Pharm., 2018, 3(2), 19-24.
[15]
Rathod, H.J.; Mehta, D.P. A Review on Pharmaceutical Gel. Int. J. Pharma Sci., 2015, 1(1), 33-47.
[16]
Gollnick, H.; Cunliffe, W.; Berson, D.; Dreno, B.; Finlay, A.; Leyden, J.J.; Shalita, A.R.; Thiboutot, D. Management of acne: A report from a global alliance to improve outcomes in acne. J. Am. Acad. Dermatol., 2003, 49(2), 254.
[http://dx.doi.org/10.1067/mjd.2003.618] [PMID: 12833004]
[17]
Bhate, K.; Williams, H.C. Epidemiology of acne vulgaris. Br. J. Dermatol., 2013, 168(3), 474-485.
[http://dx.doi.org/10.1111/bjd.12149]
[18]
Aneesh, T.P.; Rajasekaran, A. Forced Degradation Studies - A Tool for Determination of Stability in Pharmaceutical Dosage Forms. Int. J. Biol. Pharm. Res., 2012, 3(5), 699-702.
[19]
Blessy, M.; Patel, R.D.; Prajapati, P.N.; Agrawal, Y.K. Development of forced degradation and stability indicating studies of drugs—A review. J. Pharm. Anal., 2014, 4(3), 159-165.
[http://dx.doi.org/10.1016/j.jpha.2013.09.003] [PMID: 29403878]
[20]
Indrani, B.; Basak, S.; Ghosh, S.K. Isolation and characterization of acid and base degradation products in atenolol and hydrochlorothiazide and a validated selective stability-indicating HPLC–UV method for their quantification. Int. J. Adv. Pharm. Anal., 2015, 5(2), 36-41.
[21]
Bellur Atici, E.; Karlığa, B. Identification, synthesis and characterization of process related impurities of benidipine hydrochloride, stress-testing/stability studies and HPLC/UPLC method validations. J. Pharm. Anal., 2015, 5(4), 256-268.
[http://dx.doi.org/10.1016/j.jpha.2015.02.001] [PMID: 29403939]
[22]
Laha, T.K.; Sen, S.A. Validated stability indicating reversed phase high performance liquid chromatographic method of leflunomide and characterization of its degradation products through retro-synthesis. J. Appl. Pharm. Sci., 2017, 7(5), 12-17.
[23]
Rao, R.N.; Naidu, C.G.; Prasad, K.G.; Santhakumar, B.; Saida, S. Development and validation of a stability indicating assay of doxofylline by RP-HPLC: ESI-MS/MS, 1H and 13C NMR spectroscopic characterization of degradation products and process related impurities. J. Pharm. Biomed. Anal., 2013, 78-79, 92-99.
[http://dx.doi.org/10.1016/j.jpba.2013.02.004] [PMID: 23466440]
[24]
Kaushik, D.; Bansal, G. Four new degradation products of doxorubicin: An application of forced degradation study and hyphenated chromatographic techniques. J. Pharm. Anal., 2015, 5(5), 285-295.
[http://dx.doi.org/10.1016/j.jpha.2015.05.003] [PMID: 29403942]
[25]
Rao, R.N.; Ramakrishna, K.; Sravan, B.; Santhakumar, K. RP-HPLC separation and ESI-MS, 1H, and 13C NMR characterization of forced degradants including process related impurities of carisbamate: method development and validation. J. Pharm. Biomed. Anal., 2013, 77(77), 49-54.
[PMID: 23376724]
[26]
Yang, Y.; Zhu, X.; Zhang, F.; Li, W.; Wu, Y.; Ding, L. Stability-indicating HPLC method development and structural elucidation of novel degradation products in posaconazole injection by LC–TOF/MS, LC–MS/MS and NMR. J. Pharm. Biomed. Anal., 2016, 125, 165-177.
[http://dx.doi.org/10.1016/j.jpba.2016.03.034] [PMID: 27023129]
[27]
Abbas, S.S.; Elghobashy, M.R.; Shokry, R.F.; Bebawy, L.I. Stability indicating HPLC and spectrophotometric methods for the determination of bupropion hydrochloride in the presence of its alkaline degradates and related impurity. Bull. Fac. Pharm. Cairo Univ., 2012, 50(1), 49-59.
[http://dx.doi.org/10.1016/j.bfopcu.2012.02.001]
[28]
Ramisetti, N.R.; Kuntamukkala, R.; Lakshetti, S.; Sripadi, P. Identification and characterization of stress degradants of lacosamide by LC–MS and ESI-Q-TOF-MS/MS: Development and validation of a stability indicating RP-HPLC method. J. Pharm. Biomed. Anal., 2014, 95, 256-264.
[http://dx.doi.org/10.1016/j.jpba.2014.03.010] [PMID: 24699370]
[29]
Ye, Q.; Ding, W.; Rinaldi, F.; Huang, Y.; Miller, S.A.; Bolgar, M. Structural characterization of low level degradants in aztreonam injection and an innovative approach to aid HPLC method validation. J. Pharm. Biomed. Anal., 2016, 124, 358-364.
[http://dx.doi.org/10.1016/j.jpba.2016.03.017] [PMID: 26991056]
[30]
Bakshi, M.; Ojha, T.; Singh, S. Validated specific HPLC methods for determination of prazosin, terazosin and doxazosin in the presence of degradation products formed under ICH-recommended stress conditions. J. Pharm. Biomed. Anal., 2004, 34(1), 19-26.
[http://dx.doi.org/10.1016/j.japna.2003.08.009] [PMID: 14738915]
[31]
Sonune, D.P.; Kumar, M.M. Isolation, Characterization of Degradation Products of Sitagliptin and Development of Validated Stability-Indicating HPLC Assay Method for Sitagliptin API and Tablets. Int. J. Pharm. Sci. Res., 2013, 4(9), 3494-3503.
[32]
Karmarkar, S.; Yang, X.; Garber, R.; Szajkovics, A.; Koberda, M. Quality by design (QbD) based development and validation of an HPLC method for amiodarone hydrochloride and its impurities in the drug substance. J. Pharm. Biomed. Anal., 2014, 100, 167-174.
[http://dx.doi.org/10.1016/j.jpba.2014.07.002] [PMID: 25168215]
[33]
Ganorkar, S.B.; Dhumal, D.M.; Shirkhedkar, A.A. Development and validation of simple RP-HPLC-PDA analytical protocol for zileuton assisted with Design of Experiments for robustness determination. Arab. J. Chem., 2017, 10(2), 273-282.
[http://dx.doi.org/10.1016/j.arabjc.2014.03.009]
[34]
Inglot, T.; Gumieniczek, A.; Mączka, P.; Rutkowska, E. New HPLC method with experimental design and fluorescence detection for analytical study of antihypertensive mixture, amlodipine and valsartan. Am. J. Anal. Chem., 2013, 4(1), 17-23.
[http://dx.doi.org/10.4236/ajac.2013.41003]
[35]
Cela, R.; Ordoñez, E.Y.; Quintana, J.B.; Rodil, R. Chemometric-assisted method development in reversed-phase liquid chromatography. J. Chromatogr. A, 2013, 1287, 2-22.
[http://dx.doi.org/10.1016/j.chroma.2012.07.081] [PMID: 22901328]
[36]
El-Gindy, A.; Emara, S.; Shaaban, H. Development and validation of chemometrics-assisted spectrophotometric and liquid chromatographic methods for the simultaneous determination of two multicomponent mixtures containing bronchodilator drugs. J. Pharm. Biomed. Anal., 2007, 43(3), 973-982.
[http://dx.doi.org/10.1016/j.jpba.2006.09.020] [PMID: 17046190]
[37]
Bhatt, D.A.; Rane, S.I. Qbd Approach to Analytical RP-HPLC Method Development and its Validation. Int. J. Pharm. Pharm. Sci., 2011, 3(1), 179-187.
[38]
Venkatesan, S.; Kannappan, N.; Mannemala, S.S. Stability-Indicating HPLC method for the simultaneous determination of HIV tablet containing emtricitabine, tenofovir, disoproxil, fumarate, and rilpivirine hydrochloride in pharmaceutical dosage forms. Int. Sch. Res. Notices, 2014, 2014, 849149.
[39]
Kumar, L.; Sreenivasa Reddy, M.; Managuli, R.S.; Pai, K.G. Full factorial design for optimization, development and validation of HPLC method to determine valsartan in nanoparticles. Saudi Pharm. J., 2015, 23(5), 549-555.
[http://dx.doi.org/10.1016/j.jsps.2015.02.001] [PMID: 26594122]
[40]
Schmidt, A.H.; Molnár, I. Using an innovative quality-by-design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations. J. Pharm. Biomed. Anal., 2013, 78-79, 65-74.
[http://dx.doi.org/10.1016/j.jpba.2013.01.032] [PMID: 23454599]
[41]
Bossunia, M.T.I.; Urmi, K.F.; Shaha, C.K. Quality-by-design approach to stability indicating RP-HPLC analytical method development for estimation of canagliflozin API and its validation. Pharm. Methods, 2017, 8(2), 92-101.
[http://dx.doi.org/10.5530/phm.2017.8.15]
[42]
Pantović, J.; Malenović, A.; Vemić, A.; Kostić, N.; Medenica, M. Development of liquid chromatographic method for the analysis of dabigatran etexilate mesilate and its ten impurities supported by quality-by-design methodology. J. Pharm. Biomed. Anal., 2015, 111, 7-13.
[http://dx.doi.org/10.1016/j.jpba.2015.03.009] [PMID: 25828507]
[43]
Sahu, P.K.; Rao, R.N.; Cecchi, T. An overview of experimental designs in HPLC method development and validation. J. Pharm. Biomed. Anal., 2017, (17), 1-62.
[PMID: 28579052]
[44]
Kalariya, P.D.; Namdev, D.; Srinivas, R. Application of experimental design and response surface technique for selecting the optimum RP-HPLC conditions for the determination of moxifloxacin Hcl and ketorolac tromethamine in eye drops. J. Saudi Chem. Soc., 2014, 1-9.
[45]
Alifiya, S.; Shaikh, S.S.; Dedania, Z.R. QbD approach to analytical method development and validation of piracetam by HPLC. World J. Pharm. Pharm. Sci., 2016, 5(5), 1771-1784.
[46]
Ayoub, B.M. Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2016, 168, 118-122.
[http://dx.doi.org/10.1016/j.saa.2016.06.010] [PMID: 27288963]
[47]
Singh, V.; Daharwal, S. Optimization of RP-HPLC method for simultaneous estimation of lamivudine and raltegravir in binary mixture by using design of experiment. Eur. J. Anal. Chem., 2016, 12(3), 179-195.
[http://dx.doi.org/10.12973/ejac.2017.00162a]
[48]
Garg, L.K.; Reddy, V.S.; Sait, S.S.; Krishnamurthy, T.; Vali, S.J.; Reddy, A.M. Quality by design: Design of experiments approach prior to the validation of a stability-indicating HPLC method for montelukast. Chromatographia, 2013, 76(23-24), 1697-1706.
[http://dx.doi.org/10.1007/s10337-013-2509-4]
[49]
Rozet, E.; Lebrun, P.; Michiels, J.F.; Sondag, P.; Scherder, T.; Boulanger, B. Analytical procedure validation and the quality by design paradigm. J. Biopharm. Stat., 2015, 25(2), 260-268.
[http://dx.doi.org/10.1080/10543406.2014.971176] [PMID: 25357001]
[50]
Jovanović, M.; Rakić, T.; Tumpa, A.; Jančić Stojanović, B. Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities. J. Pharm. Biomed. Anal., 2015, 110, 42-48.
[http://dx.doi.org/10.1016/j.jpba.2015.02.046] [PMID: 25796982]
[51]
Karmarkar, S.; Garber, R.; Genchanok, Y.; George, S.; Yang, X.; Hammond, R. Quality by design (QbD) based development of a stability indicating HPLC method for drug and impurities. J. Chromatogr. Sci., 2011, 49(6), 439-446.
[http://dx.doi.org/10.1093/chrsci/49.6.439] [PMID: 21682993]
[52]
Sayed, N.; Hegazy, M.; Abdelkawy, M.; Abdelfatah, R. Spectrophotometric, chemometric and chromatographic determination of naphazoline hydrochloride and chlorpheniramine maleate in the presence of naphazoline hydrochloride alkaline degradation product. Bull. Fac. Pharm. Cairo Univ., 2013, 51(1), 57-68.
[http://dx.doi.org/10.1016/j.bfopcu.2012.10.002]
[53]
Akhtar, M.D.S.; Sharma, P. Overview of process validation in pharmaceutical industries. J. Pharm. Adv. Res., 2019, 2(3), 489-497.
[54]
Sahu, R.; Kumar, A.; Mishra, R.; Kumar, R. Recent development in nuclear magnetic resonance as a technique for quantitative method validation. Indian J. Pharm. Sci., 2021, 83(6), 1094-1106.
[55]
Dey, S.; Reddy, Y.V.; Swetha, B.; Kumar, S.D.; Murthy, P.N.; Sahoo, S.K.; Mohapatra, S. Method development and validation for the estimation of olopatadine in bulk and pharmaceutical dosage forms and its stress degradation studies using UV–VIS spectrophotometric method. Int. J. Pharm. Pharm. Sci., 2010, 2(14), 212-218.

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy