DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF NAPROXEN AND SUMATRIPTAN IN NASAL IN-SITU GEL FORMULATION

Abstract

Simple, precise and accurate UV-Spectrophotometric simultaneous equation methods for estimation of Naproxen (NAX) and Sumatriptan (SMP) were developed and validated as per ICH guidelines. This method involves solving of simultaneous equations based on measurement of absorbance at two wavelengths i.e. 276 nm and 228 nm (λmax of NAX and SMP) in simulated nasal fluid (SNF) at pH 7.4. Both the drugs obey the Beer’s law in the concentration ranges 2-10 and 10-50µg/ml for SMP and NAX respectively. Percent recovery for both the drugs was in the range of 99.059±0.358% indicating excellent accuracy. The methods were precise, with a relative standard deviation of less than 2% for both drugs. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus, method can be used for routine monitoring of drugs in industry for the assay of bulk drugs and commercial formulation.