Abstract

ABSORBANCE CORRECTION UV SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF CLOPIDOGREL BISULPHATE AND RIVAROXABAN

Het B. Patel*, Satish A. Patel

ABSTRACT

A reliable and cost-effective testing method for Clopidogrelbisulphate and Rivaroxaban drugs. The method uses theabsorbance correction principle which depends on differentabsorbance patterns of the two drugs at specific wavelengths.This method enables precise drug measurement because itdoes not need any separation procedure. Clopidogrelbisulphate reached its highest absorbance level at 204 nmwhile Rivaroxaban displayed its unique absorbance peak at250 nm. Researchers calculated drug concentrations byobserving absorbance at these specific wavelengths and usingappropriate absorbance correction equations. When methanolwas used as the solvent for testing, both analytes demonstratedconformity with Beer-Lambert's law between concentrationlimits of 2-12 μg/mL. The ICH Q2 (R2) requirements werefollowed in the validation of the analytical method. Parameterslinearity, precision, limit of detection, limit of quantification,and accuracy were assessed during the validation procedure. According to the study, therewas a clear correlation between the concentration levels of both medications and absorbancemeasures, which yielded findings that were very similar to a value of one. Because the percentage recoveries fell within acceptable bounds, recovery experiments validated the method's accuracy. According to the precision investigations, %RSD values remained below 2% which showed that the test results achieved both repeatability and intermediate precision. The developed absorbance correction method is therefore suitable for routine quality control

Keywords: Clopidogrel bisulphate, Rivaroxaban, Absorbance correction, UV spectroscopic, Validation, Simultaneous.