Login Register Cart 0
Generic placeholder image

Current Nanomedicine

Editor-in-Chief

ISSN (Print): 2468-1873
ISSN (Online): 2468-1881

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Specific and Sensitive RP-HPLC Method Development and Validation for the Determination of Aripiprazole: Application in Preformulation Screening of Nanoemulsion

Author(s): Santosh A. Kumbhar, Chandrakant R. Kokare, Birendra Shrivastava* and Hira Choudhury*

Volume 10, Issue 1, 2020

Page: [76 - 86] Pages: 11

DOI: 10.2174/2468187309666190823155215

Abstract

Background: It has been hypothesized that delivery of aripiprazole through nanoemulsion formulation would better deliver the drug into the central nervous system to treat major depressive conditions in psychological patients. Due course of formulation development, to determine solubility of the drug in different matrices and nanoemulsion is an important step.

Materials & Methods: Therefore, a simple, rapid and selective reversed phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of aripiprazole as per International Conference of Harmonization (ICH) guidelines. Satisfactory analysis method was employed for the quantitative determination of aripiprazole during pre-formulation development.

Results and Discussion: The separation technique was achieved using the mobile phases of methanol-acetonitrile, 80:20 (v/v) delivered at 1.0 mL.min-1 flow rate through HIQ SIL C18 250x4.6 mm (5 μm particle size) column and detected at 218 nm wavelength. The method depicted linear calibration plots within the range of 5 to 50 µg.mL-1 with a determination coefficient (r2) of 0.9991 calculated by least square regression method. The validated method was sensitive with LOD of 10.0 ng.mL-1 and 30.0 ng.mL-1 of LOQ. The intra-day and inter-day precision values were ranged between 0.37-0.89 and 0.63-1.11 respectively, with accuracy ranging from 98.24 to 100.88 and 97.03 to 100.88, respectively. This developed and validated method was found to be sensitive for the determination of aripiprazole for the first time from various oils, surfactants, co-surfactants, and nanoemulsion formulation.

Conclusion: This RP-HPLC method was successfully implemented for the quantitative determination of aripiprazole at developmental stages of nanoemulsion formulation.

Keywords: Aripiprazole, RP-HPLC, nanoemulsion, drug solubility, analytical method validation, surfactants.

« Previous
Graphical Abstract

[1]
Lenze EJ, Mulsant BH, Blumberger DM, et al. Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomised, double-blind, placebo-controlled trial. Lancet 2015; 386(10011): 2404-12.
[http://dx.doi.org/10.1016/S0140-6736(15)00308-6] [PMID: 26423182]
[2]
Whiteford HA, Degenhardt L, Rehm J, et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet 2013; 382(9904): 1575-86.
[http://dx.doi.org/10.1016/S0140-6736(13)61611-6] [PMID: 23993280]
[3]
Burris KD, Molski TF, Xu C, et al. Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther 2002; 302(1): 381-9.
[http://dx.doi.org/10.1124/jpet.102.033175] [PMID: 12065741]
[4]
McIntyre RS. Aripiprazole for the maintenance treatment of bipolar I disorder: A review. Clin Ther 2010; 32(Suppl. 1): S32-8.
[http://dx.doi.org/10.1016/j.clinthera.2010.01.022] [PMID: 20152551]
[5]
Naber D, Lambert M. Aripiprazole: a new atypical antipsychotic with a different pharmacological mechanism. Prog Neuropsychopharmacol Biol Psychiatry 2004; 28(8): 1213-9.
[http://dx.doi.org/10.1016/j.pnpbp.2004.06.020] [PMID: 15588748]
[6]
Mamo D, Graff A, Mizrahi R, Shammi CM, Romeyer F, Kapur S. Differential effects of aripiprazole on D(2), 5-HT(2), and 5-HT(1A) receptor occupancy in patients with schizophrenia: a triple tracer PET study. Am J Psychiatry 2007; 164(9): 1411-7.
[http://dx.doi.org/10.1176/appi.ajp.2007.06091479] [PMID: 17728427]
[7]
Hirose T, Uwahodo Y, Yamada S, et al. Mechanism of action of aripiprazole predicts clinical efficacy and a favourable side-effect profile. J Psychopharmacol (Oxford) 2004; 18(3): 375-83.
[http://dx.doi.org/10.1177/026988110401800308] [PMID: 15358981]
[8]
Shapiro DA, Renock S, Arrington E, et al. Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology. Neuropsychopharmacology 2003; 28(8): 1400-11.
[http://dx.doi.org/10.1038/sj.npp.1300203] [PMID: 12784105]
[9]
Kim Y, Jeon J-Y, Chung Y-C, Kim M-G. Pharmacokinetics of a new orally disintegrating tablet formulation of aripiprazole 15mg administered without water in healthy middle-aged korean subjects. Clin Ther 2015; 37(12): 2772-9.
[http://dx.doi.org/10.1016/j.clinthera.2015.10.006] [PMID: 26546405]
[10]
Li D-J, Tseng P-T, Stubbs B, et al. Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials. Prog Neuropsychopharmacol Biol Psychiatry 2017; 79(Pt B): 289-301.
[http://dx.doi.org/10.1016/j.pnpbp.2017.06.023] [PMID: 28651936]
[11]
Marder SR, McQuade RD, Stock E, et al. Aripiprazole in the treatment of schizophrenia: safety and tolerability in short-term, placebo-controlled trials. Schizophr Res 2003; 61(2-3): 123-36.
[http://dx.doi.org/10.1016/S0920-9964(03)00050-1] [PMID: 12729864]
[12]
Bapat RA, Dharmadhikari S, Chaubal TV, et al. The potential of dendrimer in delivery of therapeutics for dentistry Heliyon 2019.5: e02544..
[http://dx.doi.org/10.1016/j.heliyon.2019.e02544]
[13]
He WJ, Hosseinkhani H, Da Hong P, Chiang CH, Yu DS. Magnetic Nanoparticles for Imaging Technology. Int J Nanotechnol 2013; 10: 930-44.
[http://dx.doi.org/10.1504/IJNT.2013.058120]
[14]
Mottaghitalab F, Farokhi M, Shokrgozar MA, Atyabi F, Hosseinkhani H. Silk fibroin nanoparticle as a novel drug delivery system. J Control Release 2015; 206: 161-76.
[http://dx.doi.org/10.1016/j.jconrel.2015.03.020] [PMID: 25797561]
[15]
Alibolandi M, Abnous K, Ramezani M, Hosseinkhani H, Hadizadeh F. Synthesis of AS1411-aptamer-conjugated CdTe quantum dots with high fluorescence strength for probe labeling tumor cells. J Fluoresc 2014; 24(5): 1519-29.
[http://dx.doi.org/10.1007/s10895-014-1437-5] [PMID: 25172439]
[16]
Hosseinkhani H, Chen Y-R, He W, Hong P-D, Yu D-S, Domb AJ. Engineering of magnetic DNA nanoparticles for Tumor-Targeted therapy. J Nanopart Res 2013; 15: 1345-55.
[http://dx.doi.org/10.1007/s11051-012-1345-z]
[17]
Hosseinkhani H, He W-J, Chiang C-H, et al. Biodegradable nanoparticles for gene therapy technology. J Nanopart Res 2013; 15: 1794-809.
[http://dx.doi.org/10.1007/s11051-013-1794-z]
[18]
Abedini F, Hosseinkhani H, Ismail M, et al. Cationized dextran nanoparticle-encapsulated CXCR4-siRNA enhanced correlation between CXCR4 expression and serum alkaline phosphatase in a mouse model of colorectal cancer. Int J Nanomedicine 2012; 7: 4159-68.
[PMID: 22888250]
[19]
Ghadiri M, Vasheghani-Farahani E, Atyabi F, Kobarfard F, Mohamadyar-Toupkanlou F, Hosseinkhani H. Transferrin-conjugated magnetic dextran-spermine nanoparticles for targeted drug transport across blood-brain barrier. J Biomed Mater Res A 2017; 105(10): 2851-64.
[http://dx.doi.org/10.1002/jbm.a.36145] [PMID: 28639394]
[20]
Alibolandi M, Abnous K, Sadeghi F, Hosseinkhani H, Ramezani M, Hadizadeh F. Folate receptor-targeted multimodal polymersomes for delivery of quantum dots and doxorubicin to breast adenocarcinoma: In vitro and in vivo evaluation. Int J Pharm 2016; 500(1-2): 162-78.
[http://dx.doi.org/10.1016/j.ijpharm.2016.01.040] [PMID: 26802496]
[21]
Pandey M, Choudhury H, Yeun OC, et al. Perspectives of nanoemulsion strategies in the improvement of oral, parenteral and transdermal chemotherapy. Curr Pharm Biotechnol 2018; 19(4): 276-92.
[http://dx.doi.org/10.2174/1389201019666180605125234] [PMID: 29874994]
[22]
Gorain B, Choudhury H, Kundu A, et al. Nanoemulsion strategy for olmesartan medoxomil improves oral absorption and extended antihypertensive activity in hypertensive ratsColloids and Surfaces B: Biointerfaces 2014; 115: 286-94.
[http://dx.doi.org/10.1016/j.colsurfb.2013.12.016]
[23]
Gorain B, Choudhury H, Pandey M, Kesharwani P. Paclitaxel loaded vitamin E-TPGS nanoparticles for cancer therapy. Mater Sci Eng C 2018; 91: 868-80.
[http://dx.doi.org/10.1016/j.msec.2018.05.054] [PMID: 30033322]
[24]
Choudhury H, Gorain B, Pandey M, et al. Recent update on nanoemulgel as topical drug delivery system. J Pharm Sci 2017; 106(7): 1736-51.
[http://dx.doi.org/10.1016/j.xphs.2017.03.042] [PMID: 28412398]
[25]
Abedini F, Ebrahimi M, Roozbehani AH, Domb AJ, Hosseinkhani H. Overview on natural hydrophilic polysaccharide polymers in drug delivery. Polym Adv Technol 2018; 29: 2564-73.
[http://dx.doi.org/10.1002/pat.4375]
[26]
Sawant K, Pandey A, Patel S. Aripiprazole loaded poly(caprolactone) nanoparticles: Optimization and in vivo pharmacokinetics. Mater Sci Eng C 2016; 66: 230-43.
[http://dx.doi.org/10.1016/j.msec.2016.04.089] [PMID: 27207059]
[27]
Xu Y, Liu X, Lian R, et al. Enhanced dissolution and oral bioavailability of aripiprazole nanosuspensions prepared by nanoprecipitation/homogenization based on acid-base neutralization. Int J Pharm 2012; 438(1-2): 287-95.
[http://dx.doi.org/10.1016/j.ijpharm.2012.09.020] [PMID: 22989976]
[28]
Jamróz W, Kurek M, Łyszczarz E, et al. 3D printed orodispersible films with Aripiprazole. Int J Pharm 2017; 533(2): 413-20.
[http://dx.doi.org/10.1016/j.ijpharm.2017.05.052] [PMID: 28552800]
[29]
Choudhury H, Gorain B, Chatterjee B, Mandal UK, Sengupta P, Tekade RK. Pharmacokinetic and pharmacodynamic features of nanoemulsion following oral, intravenous, topical and nasal route. Curr Pharm Des 2017; 23(17): 2504-31.
[http://dx.doi.org/10.2174/1381612822666161201143600] [PMID: 27908273]
[30]
Patle HS, Chandewar AV, Kshirsagar MD. Development and validation of UV spectrophotometric determination of aripiprazole in bulk and tablet formuation. Int J Curr Pharm Res 2011; 3: 59-61.
[31]
Kalaichelvi R, Thangabalan B, Rao DS, Jayachandran E. UV spectrophotometric determination of aripiprazole in bulk and pharmaceutical formulation. E-J Chem 2009; 6: S87-90.
[http://dx.doi.org/10.1155/2009/542919]
[32]
Sandeep K, Induri M, Sudhakar M. Validated spectrophotometric quantification of aripiprazole in pharmaceutical formulations by using multivariate technique. Adv Pharm Bull 2013; 3(2): 469-72.
[PMID: 24312881]
[33]
Thakkar RS, Saravaia HT, Ambasana MA, Kaila HO, Shah AK. A chromatographic determination of Aripiprazole using HPLC and UPLC: A comparative validation study. Indian J Pharm Sci 2011; 73(4): 439-43.
[PMID: 22707830]
[34]
Mondal P, Rani SS, Alekhya K. A new stability indicating validated method for the determination of aripiprazole in bulk and tablet dosage form using Rp-Hplc. Int J Pharm Pharm Sci 2013; 5: 660-5.
[35]
Sastry BS, Gananadhamu S, Rao GD. RP-HPLC Determination of Aripiprazole in pharmaceutical formulations. Asian J Chem 2009; 21: 6643-6.
[36]
Kalaichelvi R, Thangabalan B, Rao DS. Validated RP-HPLC method for analysis of aripiprazole in a formulation. E-J Chem 2010; 7: 827-32.
[http://dx.doi.org/10.1155/2010/935279]
[37]
Choudhury H, Gorain B, Karmakar S, Pal TK. Development and validation of RP-HPLC method: scope of application in the determination of oil solubility of paclitaxel. J Chromatogr Sci 2014; 52(1): 68-74.
[http://dx.doi.org/10.1093/chromsci/bms206] [PMID: 23293041]
[38]
Nandi U, Das A, Roy B, Choudhury H, Gorain B, Pal TK. Development and validation of an HPLC-UV method for simultaneous determination of zidovudine, lamivudine, and nevirapine in human plasma and its application to pharmacokinetic study in human volunteers. Drug Test Anal 2013; 5(6): 485-91.
[39]
Gorain B, Choudhury H, Nandi U, Das A, Dan S, Pal TK. Development and validation of an HPLC method for simultaneous detection and quantification of Paracetamol and Etodolac in human plasma and its application to a pharmacokinetic study. J AOAC Int 2013; 96: 573-9.
[http://dx.doi.org/10.5740/jaoacint.11-457]
[40]
Choudhury H, Gorain B, Das A, Ghosh B, Pal T. Development and validation of a sensitive HPLC-MS/MS-ESI method for determination of Febuxostat: application to pharmacokinetic study. Curr Anal Chem 2014; 4: 528-36.
[41]
Gorain B, Choudhury H, Biswas E, Barik A, Jaisankar P, Pal TK. A novel approach for nanoemulsion components screening and nanoemulsion assay of olmesartan medoxomil through a developed and validated HPLC method. RSC Advances 2013; 3: 10887-93.
[42]
International conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use Ich Harmonised Tripartite guideline validation of analytical procedures: Text And Methodology Q2(R1); 2005.
[43]
Musenga A, Saracino MA, Spinelli D, et al. Analysis of the recent antipsychotic aripiprazole in human plasma by capillary electrophoresis and high-performance liquid chromatography with diode array detection. Anal Chim Acta 2008; 612(2): 204-11.
[http://dx.doi.org/10.1016/j.aca.2008.02.046] [PMID: 18358867]
[44]
Patel DS, Sharma N, Patel MC, Patel BN, Shrivastav PS, Sanyal M. Development and validation of a rapid and sensitive LC-MS/MS method for the determination of aripiprazole in human plasma: Application to a bioequivalence study. Acta Chromatogr 2014; 26: 203-27.
[http://dx.doi.org/10.1556/AChrom.26.2014.2.2]
[45]
Fofaria NM, Qhattal HSS, Liu X, Srivastava SK. Nanoemulsion formulations for anti-cancer agent piplartine--Characterization, toxicological, pharmacokinetics and efficacy studies. Int J Pharm 2016; 498(1-2): 12-22.
[http://dx.doi.org/10.1016/j.ijpharm.2015.11.045] [PMID: 26642946]
[46]
Hussain A, Singh VK, Singh OP, Shafaat K, Kumar S, Ahmad FJ. Formulation and optimization of nanoemulsion using antifungal lipid and surfactant for accentuated topical delivery of Amphotericin B. Drug Deliv 2016; 23(8): 3101-10.
[http://dx.doi.org/10.3109/10717544.2016.1153747] [PMID: 27854145]

Rights & Permissions Print Cite
Article Metrics
6
© 2024 Bentham Science Publishers | Privacy Policy