Development and Validation of a Stability Indicating Assay Method Using Hplc for Determinrtion of a Model Drug in Bulk and Pharmaceutical Dosage Form

The aim of present work was to develop a RP-HPLC method for Determination of a model drug in bulk and pharmaceutical dosage form. Agilent Chromatographic system was optimized using a Hypersil BDS C18 column (250 x 4.60 x 5μm) with mobile phase comprising of 7.5 Phosphate buffer: Acetonitrile in the ratio of 300:700. The flow rate was adjusted to 2.0 ml/min with UV detection at 215 nm. DCL were eluted with retention times of 9.30± 0.3 min respectively. Beer's Lambert's Law was obeyed over the concentration ranges of 27.97–51.94mcg/ml, for DCL. The high recovery and low coefficients of variation confirm the suitability of the method for quqntitative analysis of drug in a liquid dosage form. Statistical analysis proves that the method is sensitive and significant for the analysis of DCL in pure and in pharmaceutical dosage form without any interference from the excipients. The method was validated in accordance with ICH guidelines.