SIMUTANEOUS ESTIMATION AND METHOD DEVELOPMENT, VALIDATION OF THIOCOLCHICOSIDE AND ETODOLAC USING RP-HPLC METHOD
Ms. A. Poornima*, Dr. K. Swathi Priya, Dr. D. Nivedita, Mrs. P. R. Sudha Rani, Mr. Abhishek Sam Jeremy
Validating a method is essential to guarantee that the results it produces are accurate and consistent within the required limits. Validation serves as documented proof that the method will consistently deliver reliable results. In industrial settings, validation holds significant importance, especially with regulatory oversight. Agencies like the U.S. FDA emphasize the need for method validation as part of Good Manufacturing Practices (CGMP). The developed method was novel and simple for the simultaneous estimation of Thiocolchicoside & Etodolac by RP-HPLC. The two peaks were well resolved at 226nm in isocratic mode at retention times 3.126 and 5.929 min for Thiocolchicoside and Etodolac respectively at a run time of 15 min and flow rate 1.0 ml/min with 250mm x 4.6mm, 5μm column & Methanol: Acetonitrile: Water 30:50:20 (v/v/v) as mobile phase. % Assay values for Thiocolchicoside and Etodolac were found to be 98.99% & 99.57% respectively. Linearity was obtained in the range of 24-72 ppm & 20-60 ppm and linearity correlation coefficient was found to be 0.9910 & 0.9907 for Thiocolchicoside and Etodolac respectively. This new approach was verified using ICH guidelines and found to be specific, sensitive, precise, accurate, and linear.
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