METHOD DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF ASSAY OF SUGAMMADEX SODIUM, APREMILAST, RIOCIGUAT AND VORAPAXAR SULFATE DRUGS IN API FORM.

摘要

Objective: The objective of the present work is to develop a simple, efficient and reproducible spectrophotometric method for the quantitative estimation of Sugammadex Sodium, Apremilast, Riociguat and Vorapaxar sulfate drugs in its active pharmaceutical ingredient (API) form. Methods: The developed UV-Visible spectrophotometric method for the quantitative estimation of drugs – Sugammadex Sodium, Apremilast, Riociguat and Vorapaxar sulfate is based on measurement of absorption at a wavelength maximum (λmax) of 210nm, 230nm, 323nm and 271nm using water and methanol as diluents. Results: The method was validated in terms of specificity, precision, linearity, accuracy, and robustness as per the ICH guidelines. The method was found to be linear in the range of 33% to 167% for Sugammadex Sodium and Apremilast drug substances; 50% to 150% for Riociguat and Vorapaxar sulfate drug substances. The percentage recovery values were in the range of 99.7 to 100.9% for Sugammadex Sodium, 99.3 to 100.3% for Apremilast, 99.7 to 100.3% for Riociguat and in the range of 99.5 to 100.3% for Vorapaxar sulfate at different concentration levels. Relative standard deviation for precision and intermediate precision results were found to be less than 2%. The correlation co-efficient value observed for Sugammadex Sodium, Apremilast, Riociguat and Vorapaxar sulfate drug substances was not less than 0.99 for their respective drugs. Results obtained from the validation experiments prove that the developed method is quantified for the estimation of assay of Sugammadex Sodium, Apremilast, Riociguat and Vorapaxar sulfate drug substances. Conclusion: The developed method can be successfully applied for routine analysis, quality control analysis and also suitable for stability analysis of assay of Sugammadex Sodium, Apremilast, Riociguat and Vorapaxar sulfate in API form as per the regulatory requirements. Keywords: Sugammadex Sodium, Apremilast, Riociguat, Vorapaxar sulfate, Method Development, Validation, UV-Visible spectrophotometry.