Abstract

DEVELOPMENT AND VALIDATION OF UV METHOD FOR THE SIMULTANEOUS ESTIMATION OF RACECADOTRIL AND OFLOXACIN IN BULK DRUGS AND MARKETED FORMULATION

Kaustubh V. Gavali*, Ajij A. Shaikh, Ashpak M. Tamboli and Naziya I. Khan

Abstract

The Spectrophotometric methods Methanol: Water (80:20) used as a solvent. The wavelength used for Racecadotril and Ofloxacin sodium was 231 nm and 297 nm respectively. The simultaneous equation method was developed and validated according to the ICH guidelines. Racecadotril and Ofloxacin individually follow the Beer-Lamberts law over concentration range 5-25 μg/ml and 5–25 μg/ml respectively. Precision studies were carried out using parameter like intra-day and inter-day precision, the study showed that the results were within acceptance limit. i.e. % RSD below 2.0. The LOD was found to be 1.68μg/ml and 1.27μg/ml for Racecadotril & Ofloxacin respectively. The LOQ was found to be 5.11μg/ml and 3.84μg/ml. Accuracy of method is ascertained by recovery studies performed at different levels of concentrations (80%, 100% and 120%). The % recovery was found to be within 99-101%.

Keywords: LOD, LOQ, UV Spectrophotometry.