DEVELOPMENT AND VALIDATION OF ZERO ORDER DEIVATIVE BY UV- SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF DILTIAZEM HCL IN BULK AND ITS FORMULATION

Present study describes the spectrophotometric method development and subsequent validation of Diltiazem hydrochloride and its formulation with greater precision and accuracy. Spectrophotometric measurements were carried out using JASCO double beam (V-530 model) UV-visible spectrophotometer with a pair of 1 mm matched quartz cells and 0.1 N HCL as hydrochloric buffer. λmax was 237 nm. Linearity was observed in the concentration range 5-15μg/mL. The percentage recovery of Diltiazem hydrochloride was in the range 98.9 ? 101.7%. The precision was found to be NMT 2.0% RSD (Relative standard deviation). Proposed method was validated as per International Conference on Harmonization (ICH) guidelines. Validation studies demonstrated this method as simple, precise, accurate, specific, rapid, reliable and reproducible