DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METOPROLOL SUCCINATE AND CILNIDIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

摘要

Objective: Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Metoprolol succinate and Cilnidipine in bulk and pharmaceutical dosage form. Methods: The separation was carried out on STD Kromasil 150 C 18 (4.6 mm X 150 mm, 5 μ) column using acetonitrile: sodium dihydrogen ortho phosphate buffer (adjusted to pH 5 with 10 % OPA) in the ratio of 65: 35 % v/v as eluent. The flow rate was 0.8 ml/min and effluent was detected at 230 nm. Results: The retention time of Metoprolol succinate and Cilnidipine were found to be 2.27 and 3.26 min, respectively. The linear dynamic range was 62.5-375 μg/ml for Metorolol succinate and 12.5-75 μg/ml for Cilnidipine, respectively. Percentage recoveries for Metoprolol succinate and Cilnidipine were 99.73 – 99.93 % and 99.92 – 99.96 %, respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. Conclusion: A simple, efficient and reproducible stability indicating RP-HPLC method for the simultaneous determination of Metoprolol Succinate and Cilnidipine in pharmaceutical dosage form has been developed and validated. The developed method was also found to be precise and robust for the simultaneous determination of Metoprolol succinate and Cilnidipine in tablet dosage forms. Keywords: Metoprolol succinate, Cilnidipine, RP-HPLC, Acetonitrile, Sodium dihydrogen ortho phosphate , Orthophosphoric acid, Methanol.