RATIO SPECTRA DERIVATIVE UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE IN IMMEDIATE RELEASE TABLET

摘要

Objective: To develop and validate robust, accurate and precise UV spectrophotometric method for determination of Ketorolac Tromethamine and Phenylephrine Hydrochloride. Methods: Ratio spectra derivative method was developed using water as solvent. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. Results: Linearity of the developed method was 0.9958 and 0.9987 in the range of 4-20 ppm and 12-60 ppm for Ketorolac Tromethamine and Phenylephrine Hydrochloride respectively. % Relative standard deviation (RSD) was found to be less than 2 for Intraday precision and Intermediate precision. % recovery was found to be 98.5–100.27 % and 98.38–101.99 % for Ketorolac Tromethamine and Phenylephrine Hydrochloride respectively. Conclusion: A robust, accurate and precise UV spectrophotometric method was developed and validated as per ICH guidelines.