DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF SAXAGLIPTIN AND DAPAGLIFLOZIN IN BULK AND DOSAGE FORMAbstract
Objective: In the present work, A Simple, rapid, sensitive, precise, and reproducible, specific UV spectrophotometric method for the determination of Saxagliptin (SAXA) and Dapagliflozin (DAPI) in bulk drug and pharmaceutical dosage form were developed and validated. Methods: A simple double beam UV spectrophotometric method has been developed and validated with different parameters such as linearity, precision, repeatability, the limit of detection (LOD), Limit of Quantification (LOQ), accuracy as per ICH guidelines. Results: UV-visible spectrophotometric method, measurement of absorption at a maximum wavelength in 10 ml methanol and volume make with water solvent system as reference SAXA and DAPI were found to be at 224 nm and 274 nm respectively. The drug obeyed the Beer’s law and showed a good correlation. Beer’s law was obeyed in the concentration range 2-10 µg/ml for Saxagliptin and 4-20 µg/ml for Dapagliflozin, respectively with a correlation coefficient was 0.999. The LOD and LOQ of Saxagliptin were found to be 0.040 μg/ml and 0.01230 μg/ml, Dapagliflozin was found to be 0.1230 μg/ml and 0.5460 μg/ml, respectively. Percentage assay of SAXA and DAPI in tablets. Conclusion: The proposed method is simple, precise, accurate, and reproducible can be used for routine analysis of Saxagliptin and Dapagliflozin in bulk and tablet dosage form.
S. Ahmad *, M. R. Usman, T. Shaikh, M. Imran and R. Akhtar
Department of Quality Assurance and Pharmacognosy, Gangamai College of Pharmacy, Nagaon, Dhule, Maharashtra, India.
03 April 2020
28 June 2020
16 August 2020
01 April 2021