ABSTRACT:
Objective: HPLC is an important analytical method for determining medicinal product stability. A simple, selective, accurate, precise and reproducible stability indicating RPHPLC development and validation of S (-) Metoprolol Succinate (MS) and Efonidipine Hydrochloride Ethanoate (EFO) in Tablet Dosage Form. Material and Method: A specific and sensitive isocratic stability indicating RPHPLC method development and validated for analysis and separation of MS and EFO using mobile phase ratio is [(MeOH:ACN) (85:15%v/v)] : 10mMK2HPO4 buffer pH7 [90:10]%v/v, Agilent 5HC-C18 (2) (250mm × 4.6mm) column, with flow rate 1.0 ml/min and detection wavelength was 226nm and 20µl injection volume. The developed method was validated as per ICH Q2 (R1) for all validation parameters, which include accuracy, precision, repeatability, specificity, robustness, and detection and quantification limitations, were followed during the validation process. In order to assess degradation of MS and EFO through stability testing by being exposed to acidic, basic, oxidative, thermal, and photolytic environments. Results: The technique was validated using the ICH Q2 (R1) criteria for accuracy, precision, repeatability, specificity, robustness, and detection and quantification limitations. MS and EFO were tested for stability, and both chemicals degraded extensively in acidic, basic, oxidative, thermal, and photolytic environments. MS and EFO showed linearity in concentration ranges of 5-25g/ml and 8-40µg/ml, respectively, with correlation coefficients of 0.999. MS’s LOD and LOQ were 0.30µg/ml and 0.92µg/ml, whereas EFO were 0.19µg/ml and 0.58µg/ml. The accuracy ranged from 98.31-99.99% for MS and 98.02-99.23% for EFO. Conclusion: The developed RPHPLC technique was shown to be appropriate forth interference-free determination of these two drugs.