First derivative spectrophotometric determination of granisetron hydrochloride in presence of its hydrolytic products and preservative and application to pharmaceutical preparations
Article first published online: 31 JAN 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Drug Testing and Analysis
Volume 5, Issue 4, pages 234–241, April 2013
How to Cite
Hewala, I. I., Bedair, M. M. and Shousha, S. M. (2013), First derivative spectrophotometric determination of granisetron hydrochloride in presence of its hydrolytic products and preservative and application to pharmaceutical preparations. Drug Test Analysis, 5: 234–241. doi: 10.1002/dta.297
- Issue published online: 22 APR 2013
- Article first published online: 31 JAN 2012
- Manuscript Accepted: 12 APR 2011
- Manuscript Revised: 17 MAR 2011
- Manuscript Received: 25 NOV 2010
- hydrolytic degradation;
- first derivative;
- pharmaceutical preparations
Granisetron is a selective 5-HT3 receptor antagonist used in prevention and treatment of chemotherapy-induced nausea and vomiting. The drug is available in tablet dosage form and parenteral dosage form containing benzyl alcohol as a preservative. The main route of degradation of granisetron is through hydrolysis. The present work describes the development of a simple, rapid, and reliable first derivative spectrophotometric method for the determination of granisetron in presence of its hydrolytic products as well as the formulations adjuvant and benzyl alcohol. The method is based on the measurement of the first derivative response of granisetron at 290 nm where the interference of the hydrolytic products, the co-formulated adjuvant and benzyl alcohol is completely eliminated. The proposed method was validated with respect to specificity, linearity, selectivity, accuracy, precision, robustness, detection, and quantification limits. Regression analysis showed good correlation between the first derivative response and the concentration of granisetron over a range of 8–16 μg ml−1. Statistical analysis proved the accuracy of the proposed method compared with a reference stability indicating high performance liquid chromatography method. The described method was successfully applied to the determination of granisetron in different batches of tablets and ampoules. The assay results obtained in this study strongly encourage us to apply the validated method for the quality control and routine analysis of tablets and parenteral preparations containing granisetron. Copyright © 2012 John Wiley & Sons, Ltd.