Stability Indicating Spectrophotometric and Chemometric Methods for Determination of Aripiprazole in Presence of its Degradation Products, A Comparative Study
Date
2019
Journal Title
Journal ISSN
Volume Title
Type
Article
Publisher
Taylor & Francis
Series Info
TACL;9(2) 2019 pp 258 - 272
Scientific Journal Rankings
Abstract
Simple, accurate, selective and validated stability indicating UV spectrophotometric univariate
and multivariate methods were developed for determination of Aripiprazole in presence of its alkaline and
oxidative degradation products. The developed univariate methods; derivative ratio spectra-zero crossing,
successive derivatives of ratio spectra and mean centering of ratio spectra. The first one used the amplitude of
the first derivative ratio signals at 303.0 nm, the second method depended on the successive derivative of ratio
spectra in two steps and measuring the absorbance of Aripiprazole at 281.0 nm and the third one measured the
mean centered values oat 294.0 nm. Two chemometric multivariate methods were applied; principal component
regression (PCR) and partial least-squares regression (PLS). The selectivity of the proposed methods was
confirmed using laboratory-prepared mixtures. The obtained results were statistically compared with those
obtained with the manufacturer HPLC method, showing no significant difference with in accuracy and precision.
These methods could be applied as stability indicating methods for the determination of Aripiprazole in presence
of its degradation products, in bulk powder or in pharmaceutical formulations.
Description
MSA Google Scholar
Keywords
University of Aripiprazole, Degradation, Spectrophotometry
Citation
1. ICH-International Conference on Harmonization, of Technical Requirements for registration of Pharmaceuticals for Human Use Topic Q2 (R1), Validation of Analytical Procedures: Text and Methodology, Geneva, Switzerland, 2005. 2. Naber, D. and Lambert, M. (2004). Aripiprazole: a new atypical antipsychotic with a different pharmacological mechanism. Prog Neuropsychopharmacol Biol Psychiatry. 28(8): 1213-1219. 3. DeLeon, A., Patel, N.C. and Crismon, M.L. (2004). Aripiprazole: A comprehensive review of its pharmacology, clinical efficacy, and tolerability. Clin Therap. 26(5): 649-666. 4. Sweetman, S.C. (2005). Martindale” The Complete Drug Reference”. London, Pharmaceutical Press.p. 5. Mondal, P., Rani, S.S. and Alekhya, K. (2013). 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. 5(4): 660-665. 6. Narayana, M.B.V. and Chandrasekhar, K.B. (2012). A Validated specific stability-indicating RP-HPLC method for Aripiprazole and its related substances. J Chem Pharm Res. 4(9): 4426- 4435. 7. Pai, N.R. and Dubhashi, D.S. (2010). Development of stability indicating, validated HPLC method for quantitative determination of Aripiprazole and its impurities. Der Pharmacia Lettre. 2 (4): 1-10. 8. Helmy, A.G., Abdel-Gawad, F.M. and Mohamed, E.F. (2012). Spectrophotometric study on determination of Aripiprazole in tablets by charge-transfer and ion-pair complexation reactions with some acceptors. Asian J. Pharm. Ana. 2(1): 12-19. 9. Jain, R.,. Kashaw, S.K., Jain, R., Mishra, P. and Kohli, D.V. (2011). Visible spectrophotometric method for the determination of Aripiprazole in tablets. Indian J Pharm Sci. 73(1): 74-76. 10. Kalaichelvi, R., Thangabalan, B., Rao, D.S. and Jayachandran, E. (2009). UV spectrophotometric determination of Aripiprazole in bulk and pharmaceutical formulation. E-J.Chem. 6(S1): S87-S90. 11. Sandeep, K., Induri, M. and Sudhakar, M. (2013). Validated spectrophotometric quantification of Aripiprazole in pharmaceutical formulations by using multivariate technique. Adv Pharm Bull. 3(2): 469-472. 12. Kalaichelvi, R., Thangabalan, B. and Rao, D.S. (2010). Validated RP-HPLC method for analysis of Aripiprazole in a formulation. E-J.Chem. 7(3): 827-832. 13. Kubo, M., Mizooku, Y., Hirao, Y. and Osumi, T. (2005). Development and validation of an LC-MS/MS method for the quantitative determination of Aripiprazole and its main metabolite, OPC-14857, in human plasma. J. Chromatogr. B. 822(1-2): 294-299. 14. Patel, D.P., Sharma, P., Sanyal, M. and Shrivastav, P.S. (2013). SPE-UPLC-MS/MS method for sensitive and rapid determination of Aripiprazole in human plasma to support a bioequivalence study. J. Chromatogr. B. 925: 20-25. 15. Asangil, D., Tasdemir, I.H. and Kiliç, E. (2012). Adsorptive stripping voltammetric methods for determination of Aripiprazole. J. Pharm. Anal. 2(3): 193-199. 16. Merli, D., Dondi, D., Ravelli, D., Tacchini, D. and Profumo, A. (2013). Electrochemistry and analytical determination of Aripiprazole and Octoclothepin at glassy carbon electrode.J. Electroanal. Chem. 711: 1-7. 17. M.Amer, S., El-Maraghy, C.M., Salem, H. and Nebsen, M. (2016). Quantitative determination of citalopram hydrobromide by spectrophotometry and chemometry in presence of its degradation products and additives in pharmaceutical preparation. Analytical Chemistry: An Indian Journal. 16(2): 53-62. 18. Miller, J.N. and Miller, J.C. (2005). Statistics and Chemometrics for Analytical Chemistry. England, Harlow, Pearson Education Limited.