Development and validation of UV spectroscopic method for simultaneou estimation of dapagliflozin and saxagliptin in synthetic mixture

Authors

  • Mohd.Zameeruddin Department of Quality Assurance Indira College of Pharmacy, Vishnupuri, Nanded, Maharashtra, India.
  • Sandhya S. Bundel Department of Quality Assurance Indira College of Pharmacy, Vishnupuri, Nanded, Maharashtra, India.
  • Vishvanath B. Bharkad Department of Quality Assurance Indira College of Pharmacy, Vishnupuri, Nanded, Maharashtra, India.
  • Hajera N. Khan Department of Quality Assurance Indira College of Pharmacy, Vishnupuri, Nanded, Maharashtra, India.
  • Thoke Sandip T Department of Quality Assurance Indira College of Pharmacy, Vishnupuri, Nanded, Maharashtra, India.

DOI:

https://doi.org/10.61096/ijpar.v8.iss1.2019.59-66

Keywords:

Dapagliflozin, Saxagliptin, Antidiabetic, Spectrophotometric analysis, Simultaneous equation method

Abstract

Aim

Simple, precise and accurate UV-Spectrophotometric Simultaneous Equation method for estimation of Dapagliflozin and Saxagliptin were developed and validated as per ICH guidelines.

Experimental and Results

The objective of the work is to develop UV spectroscopic method for simultaneous estimation of Dapagliflozin (DAPA) and Saxagliptin (SAXA). This Method involve solving of simultaneous equations based on measurement of absorbance at two wavelengths 223 nm and 212 nm. Both the drugs obey the Beer’s law in the concentration ranges 4-24 µg/mL and 5-50 µg/mL respectively. Results of the methods were validated statistically. Novel, simple, sensitive, rapid, accurate and economical Spectrophotometric methods have been developed for simultaneous estimation of Dapagliflozin and Saxagliptin .The method can be used to estimate the amount of Dapagliflozin and Saxagliptin in mixture containing Dapagliflozin and Saxagliptin.

Conclusion

The results of estimation and validation parameters like accuracy, precision, ruggedness, linearity and range were studied for all the developed methods and were found to be within limits. The proposed method can be adopted for routine quality control for estimation of drug in formulation.

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Published

2022-09-01

How to Cite

Mohd.Zameeruddin, Sandhya S. Bundel, Vishvanath B. Bharkad, Hajera N. Khan, & Thoke Sandip T. (2022). Development and validation of UV spectroscopic method for simultaneou estimation of dapagliflozin and saxagliptin in synthetic mixture. IJPAR JOURNAL, 8(1), 59–66. https://doi.org/10.61096/ijpar.v8.iss1.2019.59-66