Practical Implication of Stability Indicating Chromatographic Method for Estimation of Clomipramine Hydrochloride and its Related Substances from Capsule Dosage Form

Abstract

Clomipramine Hydrochloride is Tricyclic antidepressants (TCAs) drug which cause increased concentration of monoamines in the synaptic cleft, ultimately resulting in antidepressant effect. Literature reveals that all the reported methods are developed for estimation of Clomipramine Hydrochloride (CLH) in bulk and solid dosage form. My research is based on estimation of CLH and its related substances from capsule dosage form by HPLC method. A rapid, precise, selective and sensitive and accurate stability-indicating High Performance Liquid Chromatographic (HPLC) method for estimation of Clomipramine Hydrochloride and its related substances from capsule dosage form was developed and validated in the present work. The chromatographic separation was performed by using BDS Hypersil C18, 250 X 4.6 mm, 5 μ with 2 gm/L Tetra Butyl Ammonium Hydrogen Sulphate (TBAS) in Water (pH 2.5): Methanol (40:60 v/v) mobile phase, at a flow rate of 1.2 ml/min. The method was validated according to ICH guidelines. The effluent was monitored using a UV detector set at 252nm. The retention time for CLH was observed at 6.2 min. Impurity spiked A, B, C, are retained at 7.8, and 9.4, 3.6, min respectively. The linearity of CLH and impurities was in the range of 1050–1800 μg/ml and 0.7–4.5μg/ml respectively. The developed method was successfully applied to the analysis of the drugs in their commercial dosage form.