DOI:
VOLUME - 9 ISSUE - 3 JULY 2020
Patel Aneesh Kumar*, Dr. Omray Lavakesh, Soni Pushpendra
Radharaman Institute of Pharmaceutical Sciences, Bhopal, Madhya Pradesh, India
ABSTRACT
Simple, precise, and accurate UV-Spectrophotometric simultaneous equation method for estimation of Dapagliflozin (DAPA) and Saxagliptin (SAXA) was developed and validated as per ICH guidelines. This Method involves solving simultaneous equations based on the measurement of absorbance at two wavelengths 222 nm and 276 nm (λmax of SAXA and DAPA) in phosphate buffer pH 6.8. Both the drugs obey Beer's law in the concentration ranges 5-25μg/ml. % Recovery for both the drugs was in the range of 98.44-99.05% 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 analyses were found to be in good accordance with the prescribed values. Thus, the method can be used for routine monitoring of drugs in the industry for the assay of bulk drugs and commercial formulation (QTERN tablets, Astra Zeneca).
Keywords:
Dapagliflozin, Saxagliptin,
Spectrophotometric analysis, HPLC
method, simultaneous estimation.