A selective stability-indicating RP-HPLC method has been developed and validated for analysis of Domperidone in bulk drug. Reversed phase chromatography was performed on a C18 column with Methanol: Ammonium acetate buffer, 60:40 (%, v/v), as mobile phase at a flow rate of 1.4 ml/min. Detection was performed at 287 nm and a sharp peak was obtained for Domperidone at a retention time of 7.83 ±0.01 min. The results of analysis have been validated as per ICH guidelines. It showed a linear response in the concentration range of 20-120 µg/ml; the regression coefficient was 0.998 and the linear regression equation was y = 20166x + 15030. The detection and quantification limits were 2.79 and 8.54 µg ml-1 respectively. The average percentage recovery for Domperidone was found to be 100.05%. It was subjected to acidic, alkaline, neutral, oxidative hydrolysis and dry heat condition. The result of degradation studies indicated that it was highly susceptible to the oxidative degradation and moderately susceptible to acidic, alkaline and neutral hydrolysis. The degradation products of Domperidone were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for routine analysis of Domperidone in bulk drug in stability samples.
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