DEVELOPMENT AND VALIDATION OF REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF OLANZAPINE AND ARIPIPRAZOLE IN SYNTHETIC MIXTURES

  • MEGHA PATEL Department of Pharmacy, Ganpat University, Kherva, Gujarat, India.
  • PARESH PATEL Department of Pharmaceutical Chemistry, Ganpat University, Kherva, Gujarat, India.
  • DHARA PATEL Department of Pharmaceutical Quality Assurance, Pioneer Pharmacy Degree College, Vadodara, Gujarat, India.

Abstract

Objective: A simple, rapid, accurate, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of olanzapine (OLZ) and aripiprazole (APR) in synthetic mixtures.


Methods: The stationary phase used for chromatographic separation was Phenomenex C18 column (250 mm × 4.6 mm i.d, particle size 5 μm) and mobile phase used for separation was methanol: Phosphate buffer (pH 3) taken in ratio of 75:25 %v/v. The flow rate was used 1.0 ml/min at room temperature and drugs detected at 240 nm with injection volume 20 μL.


Results: The retention time for OLZ and APR was found to be 4.231 and 6.523 min, respectively. The linearity was performed using a concentration range of 0.5–3.0 for both drugs. The correlation coefficient was found to be 0.999 for OLZ and APR. The % purity of both the drug was found to be 98–102%. The proposed RP-HPLC method has been validated, according to International council on harmonization Q2 (B) guidelines.


Conclusion: There was no interference of any diluents and excipients in the determination of drugs from synthetic mixture. Hence, the developed method can be used for routine quality control analysis.

Keywords: Olanzapine, Aripiprazole, Reverse-phase high-performance liquid chromatography, Validation

References

1. Freudenreich O, Goff DC. Antipsychotic combination in schizophrenia. A review of efficacy and risks of current combinations. Acta Psychiatr Scand 2002;106:323-30.
2. Kapur S, Zipursky RB, Remington G, Jones C, DaSilva J, Wilson AA, et al. 5-HT2 and D2 receptor occupancy of olanzapine in schizophrenia: A PET investigation. Am J Psychiatry 1998;155:921-8.
3. Yokoi F, Grunder G, Biziere K, Stephane M, Dogan AS, Dannals RF, et al. Dopamine D2 and D3 receptor occupancy in normal humans treated with the antipsychotic drug aripiprazole (OPC 14597): A study using positron emission tomography and [11C] raclopride. Neuropsychopharmacology 2002;27:248-59.
4. Moore H, West AR, Grace AA. The regulation of forebrain dopamine transmission: Relevance to the pathophysiology and psychopathology of schizophrenia. Biol Psychiatry 1999;46:40-55.
5. Millan MJ, Gobert A, Newman-Tancredi A, Lejuene F, Cussac D, Rivet JM. S33084, a novel, potent, selective, and competitive antagonist at dopamine D3-receptors: I. Receptor, electrophysiological and neurochemical profile compared with GR218, 231 and L741, 626. J Pharmacol Exp Ther 2000;293:1048-62.
6. Drug Profile of Olanzapine. Available from: https://www.pubchem.ncbi.nlm.nih.gov/compound/Olanzapine. [Last accessed on 2018 Jan 21].
7. Drug Profile of Aripiprazole. Available from: https://www.pubchem.ncbi. nlm.nih.gov/compound/aripiprazole. [Last accessed on 2018 Jan 21].
8. Krebs A, Starczewska B, Puzanowska-Tarasiewicz H, Ïled J. Spectrophotometric determination of olanzapine by its oxidation with N-bromo succinimide and cerium (IV) sulphate. Anal Sci 2006;22:829-33.
9. Pradhan KS, Kumari S, Samanta RR. Development and validation of a stability indicating UV spectroscopic method for olanzapine in bulk and pharmaceutical dosage forms. Int J Pharm Pharm Sci 2014;6:67-72.
10. Firdous S, Aman T, Nisa AU. Determination of olanzapine by UV spectrophotometry and non-aqueous titration. Chem Soc Pak 2005;27:163-7.
11. Prasad KV, Kumar JM, Reddy MV, Prabhakar G, Sankar DG. Spectrophotometric determination of olanzapine in pharmaceutical preparations. Asian J Chem 2003;15:1127-30.
12. Sankar DG, Kumar JM, Latha PV. Spectrophotometric estimation of sisomicin and olanzapine. Asian J Chem 2005;17:1331-33.
13. Zhou Z, Li X, Li K, Xie Z, Cheng Z, Peng W, et al. Simultaneous determination of clozapine, olanzapine, risperidone and quetiapine in plasma by high-performance liquid chromatography-electrospray ionization mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2004;802:257-62.
14. Bogusz MJ, Kruger KD, Maier RD, Erkwoh R, Tuchtenhagen F. Monitoring of olanzapine in serum by liquid chromatography-atmospheric pressure chemical ionization mass spectrometry. J Chromatogr B 1999;732:257-69.
15. Rani AP, Sekaran B. Development of HPLC method for the determination of olanzapine in bulk and dosage forms. J PharmTech Res 2009;1:654-57.
16. Minase AS, Dole MN, Sawant SD. Development and validation of analytical method for simultaneous estimation of cilnidipine and olmesartan medoxomil in bulk and T dosage form by RP-HPLC. Int J Pharm Pharm Sci 2014;6:508-11.
17. Raggi MA, Casamenti G, Mandrioli R, Izzo G, Kenndler E. Quantitation of olanzapine in its metabolites by HPLC, CZE, derivative spectrometry and linear voltammetry. J Pharm Biomed Anal 2000;23:973-81.
18. Elian AA. Fatal overdose of olanzapine. Forensic Sci Int 1998;91:231.
19. Zhang M, Jia J, Chuan LU. Development and validation of a liquid chromatography-isotope dilution tandem mass spectrometry for determination of olanzapine in human plasma and its application to bioavailability study. Acta Pharm Sin 2010;45:767-71.
20. Raja A, Venkateshwar RJ. Development and validation of new RP-UPLC method for the quantitative determination of olanzapine in tablet dosage form. Asian J Pharm Clin Res 2013;6:178-81.
21. Rao DV, Shetty S, Satheesh K, Radhakrishnanand P, Himabindu V. A stability indicating RPLC method for aripiprazole. Indian J Anal Chem 2008;7:444-53.
22. Kumar MV, Muley PR. Determination of aripiprazole in bulk drug and solid dosage forms by RP-HPLC method. Indian Pharm 2005;4:71-5.
23. Koduri SV, Buchireddy SR, Madhusudhan G, Mukkanti K, Srinivasulu P. Stress degradation studies on aripiprazole and development of a validated stability indicating LC method. Chromatographia 2008;68:635-40.
24. Liu H, Jiang Y, Hao X. Determination of aripiprazole by nonaqueous reversed-phase high performance liquid chromatography. Se Pu 2005;23:563.
25. Sastry BS, Gananadhamu S, Devala RG. RP-HPLC determination of aripiprazole in pharmaceutical formulations. Asian J Chem 2009;21:6643-46.
26. Kirschbaum KM, Muller MJ, Zernig G. Therapeutic monitoring of aripiprazole by HPLC with column-switching and spectrophotometric detection. Clin Chem 2005;51:1718-21.
27. Lancelin F, Djebrani K, Tabaouti K, Kraoul L, Brovedani S, Paubel P, et al. Development and validation of a high-performance chromatography method using diode array detection for the simultaneous quantification of aripiprazole and dehydro-aripiprazole in human plasma. J Chromatogr B 2008;867:15-9.
28. Musenga A, Saracino MA, Spinelli D, Rizzato E, Boncompagni G, Kenndler E, 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;612:204-21.
29. Shimokawa Y, Akiyama H, Kashiyama E, Koga T, Miyamoto G. High performance liquid chromatographic methods for the determination of aripiprazole with ultraviolet detection in rat plasma and brain: Application to the pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci 2005;821:8-14.
30. Zuo XC, Wang F, Xu P, Zhu RH, Li HD. LC-ESI-MS for rapid and sensitive determination of aripiprazole in human plasma. Chromatographia 2006;64:387-91.
31. International Conference on Harmonization. Q2B Validation of Analytical Procedures: Methodology. Geneva: IFPMA; 1996.
Statistics
27 Views | 38 Downloads
Citatons
How to Cite
PATEL, M., P. PATEL, and D. PATEL. “DEVELOPMENT AND VALIDATION OF REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF OLANZAPINE AND ARIPIPRAZOLE IN SYNTHETIC MIXTURES”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 8, June 2020, pp. 162-8, doi:10.22159/ajpcr.2020.v13i8.38278.
Section
Original Article(s)