STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TRANEXAMIC ACID AND ETHAMSYLATE IN TABLET DOSAGE FORM
Priyanka P. Patel*, Shailesh V. Luhar and Dr. Sachin B. Narkhede
ABSTRACT
A simple, accurate, precise Stability Indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) Method was developed and validated for the simultaneous estimation of Tranexamic acid and Ethamsylate tablet dosage form using C18 column Hypersil (250mm× 4.6mm, 5μm) with Mobile Phase Phosphate Buffer: Methanol (25:75 v/v) pH was adjusted to 3.5 by addition of Orthophosphoric acid at a Flow rate of 1mL/min. Detection was carried out at wavelength 215nm. Retention time for Tranexamic acid and Ethamsylate was found to be 6.58min and 3.27min respectively. The Forced Degradation was carried out using Acid hydrolysis, Alkaline hydrolysis, Oxidative degradation, Photolytic degradation and Thermal degradation. The Forced Degradation study indicates that Tranexamic acid significantly degrade under Photolytic degradation and Ethamsylate under Acid hydrolysis. Linearity of both the drugs was observed between 25- 75μg/mL. The LOD of Tranexamic acid and Ethamsylate is found to be 3.65μg/mL and 4.06μg/mL respectively. The LOQ of Tranexamic acid and Ethamsylate is found to be 11.08μg/mL and 12.31μg/mL respectively. The Accuracy was performed at 80% to 120% and was found to be in between 99.88% to 100.18% and 99.50% to 99.87% for TRX and ETM respectively. Assay percentage for Tranexmic acid and Ethamsylate was found to be 102.50% and 96.72% respectively.
Keywords: Tranexamic acid, Ethamsylate, RP-HPLC Method, Validation.
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