STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF CLOMIPRAMINE HYDROCHLORIDE CAPSULES BY RP-HPLC

A simple, precise, and accurate RP-HPLC method has been developed and validated for the quantitative analysis of clomipramine hydrochloride in capsule dosage form. An isocratic separation was achieved using by Inertsil ODS 3V (250X4.6 mm); 5µm particle size column with a flow rate of 1.2ml/min and PDA detector at 254nm. The mobile phase consisted of pH 3.2 buffer solution and Acetonitrile (50:50% v/v). The Diluent consisted of methanol 100%v/v. It is validated for specificity, linearity, precision, accuracy and robustness. The specificity of the method was determined by comparing interference from the placebo and by stress testing the drug product (forced degradation). The method was linear over the concentration range 4–200 μg/ml (r2 = 0.999). The accuracy of the method was between 98.9–99.5%. The method was found to be Robust and suitable for the quantitative analysis of clomipramine hydrochloride in capsule dosage form. Degradation products resulting from the stress studies did not interfere with the detection of clomipramine hydrochloride peak in chromatogram, demonstrating the stability-indicating power of method.