DEVELOPMENT, VALIDATION & STRESS DEGRADATION STUDIES OF TRIPROLIDINE BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHGY (RP-HPLC)

To develop a simple, selective and precise and rapid reverse phase high performance liquid chromatography method for the development and validation, stress degradation studies of Troprolidine in bulk and Pharmaceutical dosage forms. Methods: The chromatographic separations was performed by Agilent Polaris C18 column (150 X 4.6 mm id, ODS 2,5µ m) using methanol: 0.1% ortho-phosphoric acid in water (65:35) as mobile phase at flow rate of 0.1 mL/min with injection volume 20 µL and the detection was carried out using UV detector at 232nm. The method was validated as per ICH guidelines. Results: The retention time for Troprolidine was found to be 1.88 min respectively . The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 1.01-10.05µg/mL. The correlation coefficient and percent recovery for Troprolidine were found to be 0.9989 and 100.66 respectively. The influence of Acid, Alkaline, Oxidative stress, Photolytic stress condition on Troprolidine was studied. Results indicated completed degradation in Alkaline medium. Conclusion: The developed method was successfully validated in accordance to ICH guidelines. This method is simple, selective, linear and precise accurate and sensitive and can be used for routine analysis of bulk samples.