Development and Validation of Stability Indicating RP-HPLC Method for the Determination of Impurity Profile in Gamendazole: Experimental Male Oral Contraceptive

Autor: Ramadevi Bhoomireddy, Purnachand Dasari, Madhusudhanreddy Bethi, Kameswarrao ChVSL, Arava Veera Reddy
Rok vydání: 2015
Předmět:
Zdroj: Journal of Liquid Chromatography & Related Technologies. 38:1303-1314
ISSN: 1520-572X
1082-6076
Popis: A novel RP-HPLC method has been developed for the simultaneous determination of Gamendazole and its process impurities and degradation impurities. Chromatographic separation was achieved on a C18 column (size: 250 mm × 4.6 mm; 5 µm particle size) using a gradient program at a flow rate of 1.0 mL/min and an injection volume of 10 µL with 210 nm detection. The mobile phase was water–acetonitrile (pH of water was adjusted to 3.0 with orthophosphoric acid) through gradient elution.The product was subject to stress conditions like acid, base, peroxide, thermal, and photolytic degradation. Similar degradants were observed in acid and base degradation. No degradants were observed in peroxide degradation. Several new degradants were observed in photolytic degradation. However, no interference was observed due to degradation impurities and Gamendazole, known impurities and unknown impurities.As part of the method validation, specificity, limit of detection (LOD), limit of quantitation (LOQ), linearity, accuracy, p...
Databáze: OpenAIRE
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