Abstract
Author(s): DEVELOPMENT AND VALIDATION OF HPLC METHOD OF DISSOLUTION TEST FOR METOPROLOL SUCCINATE AND CILNIDIPINE
A reverse phase high performance liquid chromatographic (RP-HPLC) method suitable for simultaneous determination of Metoprolol Succinate and Cilnidipine dissolution of solid dosage forms in pharmaceuticals has been developed. Chromatographic separation was performed on a Empower 2 software. ELIPSE Phenomenax C18, 150X4.5mm, 5μ,(Make: Waters) column using a mobile phase of buffer utilizing OPA buffer ( pH 3.0): Methanol (70:30%v/v). The effluent flow rate monitored at 1.0mL/minute, injection volume was 10μL and detected by ultraviolet at 285nm. The retention times of metoprolol succinate and cilnidipine 2.590 and 4.047minutes, respectively. The total run time was 6minutes within which the drug product. The developed method has been validated for specificity, precision, linearity, accuracy, ruggedness and robustness. Additionally, the conditions of the dissolution test for metoprolol succinate and cilnidipine tablets were presented byusing: paddle at 50rpm stirring speed; medium volume of 900mL; temperature at 37±0.5°C; and pH 6.8 phosphate buffer used as dissolution medium. The average percentage drug release was found to be in between 95% to 105% within 30minutes for both drugs. Theproposed analytical and dissolution method can be applied successfully for the quality control of commercial metoprolol succinate and cilnidipine tablets and the comparison of in vitro dissolution of combination drug products