Abstract

A NOVEL VALIDATED Q - ABSORBANCE RATIO METHOD FOR SIMULTANEOUS ESTIMATION OF OMEPRAZOLE AND ONDANSETRON IN BULK AND PHARMACEUTICAL PREPARATION

Satish A. Patel*, Kalpesh N. Patel and Mayank R. Patel

ABSTRACT

A simple, rapid, fast, accurate, economical and precise UV spectrophotometric Q - absorbance ratio method (in accordance with ICH guidelines) was developed and validated for simultaneous estimation of Omeprazole and Ondansetron in tablet dosage form. The method involved Q-absorption ratio analysis using two wavelengths, with one being the λmax of Omeprazole (205 nm) and the other being the isoabsorptive point of both drugs (236 nm). Beer’s law was obeyed in the concentration range between 2 and 12 μg/mL for both Omeprazole and Ondansetron with correlation coefficients of more than 0.999. The results of analysis have been validated statistically and by recovery studies as per ICH guidelines. The mean percent recovery of triplicate samples at each level for both drugs was 99.58 -99.71% for Omeprazole and 98.25-100.2% for Ondansetron. The method was found to be simple, precise, reproducible, rapid, and economical. Hence, it could be used in the analysis of laboratory samples and marketed formulations containing these two drugs in the future.

Keywords: Q-absorbance ratio method, Omeprazole, Ondansetron, ICH guideline, Validation.