Novel UV Spectrophotometer Methods for Quantitative Estimation of Empagliflozin (EMPA) and Linagliptin (Lina) Using Mixed Hydrotropy Solubilization

Abstract

Simple, precise accurate, novel  and safe UV-Spectrophotometric simultaneous equation method developed for the simultaneous estimation of poorly water-soluble drugs Empagliflozin (EMPA) and Linagliptin (LINA) in tablet dosage form using 2M ammonium acetate: 2M sodium citrate and (50:50% W/W) as mixed hydrotropic solution and validated as per ICH guidelines. This Method involves solving of simultaneous equations based on measurement of absorbance at two wavelengths 270 nm and 294 nm (λmax of EMPA and LINA) in hydrotropic solutions. Ammonium acetate and sodium citrate solution did not show any absorbance above 240 nm and thus no interference in the estimation of drugs was seen. EMPA and LINA follow Beers law in the concentration range of 10-50mg/ml and 5-25mg/ml (r2 = 0.999). % Recovery for both the drugs was in the range of 98.50 to99.23 % 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.