First derivative spectrophotometric determination of granisetron hydrochloride in presence of its hydrolytic products and preservative and application to pharmaceutical preparations

Abstract

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.

Novel Disposable Potentiometric Sensor for Determination of Granisetron in Surface Water Samples and Pharmaceutical Formulations

“…High-performance liquid chromatographic (HPLC) methods with different detectors including RP-HPLC [7][8][9][10], HPLC-tandem mass spectrometry [11], and HPLC with DAD detection [12] were reported for determination of GST in the literature. Derivative spectrophotometry technique was suggested for the estimation of granisetron hydrochloride in presence of other degradation products [13]. Sensitive visible spectrophotometric analysis protocols were introduced for determination of GST including the formation of a chloranilic acid (CA)-GST charge-transfer complex with high molar absorptivity.…”

In situ polymerization and FT-IR characterization of poly-glycine on pencil graphite electrode for sensitive determination of anti-emetic drug, granisetron in injections and human plasma

“…Various analytical methods were reported for quantitative determination of GRN in bulk, different pharmaceutical and biological samples, as spectrophotometric, 14,15 spectro-uorimetric, 16 HPTLC, 17,18 and HPLC [19][20][21][22] methods. Electrochemical techniques are widely used nowadays for their high sensitivity, selectivity, cost effective and high sample throughput within short analysis time.…”