Development of Stability Indicating Reverse Phase HPLC Method for Aripiprazole from Solid Dosage form

DOI:

https://doi.org/10.37285/ijpsn.2009.2.2.12

Authors

  • Pankaj Nerkar
  • Parag Gide
  • Abhishek Chitnis
  • Hitendra Mahajan
  • Surendra Gattani

Abstract

Aripiprazole is a novel antipsychotic drug, generally used in schizophrenia and known to act as a partial agonist at D2 and 5 –HT2A receptors. Since stability indicating method is required to discriminate between the intact analyte and degradation products, the present work is aimed at performing purposeful degradation of aripiprazole by exposing it to various pH conditions, oxidative conditions, dry heat and sunlight. Also it describes the final method of analysis of aripiprazole from the tablets. The chromatographic analysis was carried out on HiQSil C8 column (250 X 4.6 mm, 5 µm), mobile phase was Acetonitrile: Potassium Phosphate buffer (pH =3, 100 mM), (40:60 V/V); injection volume 100 µL, detection was carried out at λmax 225nm. Flow rate was 1.0 ml/min. The developed stability indicating method for aripiprazole was validated as per International Conference on Harmonization (ICH) guidelines.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Aripiprazole, Stability indicating method, Purposeful degradation, ICH

Downloads

Published

2009-08-31

How to Cite

1.
Nerkar P, Gide P, Chitnis A, Mahajan H, Gattani S. Development of Stability Indicating Reverse Phase HPLC Method for Aripiprazole from Solid Dosage form. Scopus Indexed [Internet]. 2009 Aug. 31 [cited 2024 May 18];2(2):572-81. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/465

Issue

Vol. 2 No. 2 (2009): July-September 2009

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

References

Bolton S., Pharmaceutical Statistics, Practical and Clinical Applications, J. Swarbrick, Ed., Volume 44, 2nd Edition, Marcel Dekker, New York, (1990)

Ermer J., McB J. H., Miller, Eds., Method Validation in Pharmaceutical Analysis, A Guide to Best Practice, Wiley VCH, Weinheim, (2005) 80 – 98.

International Conference on Harmonization (ICH), Validation of Analytical Methods: Definitions and Terminology, ICH Q2 A, (1994).

International Conference on Harmonization (ICH), Validation of Analytical Methods: Methodology, ICH Q2 B, (1996)

Kiser M. M., Dolan J. W. Selecting the Best Curve Fit, LC-GC Europe, 2, 17 (3) (2004) 138–143

Kubo M., Mizooku Y., Hirao Y., Osumi T., 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. of Chroma. B, 822(2005) 294-299.

Nagaraja N. V., Paliwal J. K., Gupta R. C., Choosing the calibration model in assay validation, Journal of Pharmaceutical and Biomedical Analysis, 20 (1999) 433 – 438

Shimokawa Y., Akiyama H. , Kashiyama E., Koga T., High performance liquid chromatographic methods for the determination of aripiprazole with ultraviolet detection in rat plasma and brain, application to the pharmacokinetic study, J. of Chroma. B, 821 (2005) 8-14.

Singh S., Bakshi M., Guidance on the conduct of stress tests to determine inherent stability of drugs, Pharmaceutical technological Asia September/ October 2000, 24-35.

Snyder L. R., Kirkland J. J., Glajch J. L., Practical HPLC Method Development, 2nd Edition, John Wiley and Sons, New York, (1997)