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Abstract

STABILITY INDICATING HPLC METHOD DEVELOPMENT FOR THE ESTIMATION OF DAPAGLIFLOZIN AND SITAGLIPTIN IN MARKETED FORMULATION

Mahima Vishwakarma*1, Deepak Kumar Basedia1, Sunil shah2

1Technocrats Institute of Technology-Pharmacy, Bhopal (M.P.)
2TIT-College of Pharmacy, Bhopal (M.P.)

ABSTRACT

A reliable and sensitive high-performance liquid chromatography (HPLC) method was developed and validated for the simultaneous determination of Dapagliflozin (DAPA) and Sitagliptin (SITA) in tablet formulations. The method was optimized for accuracy, precision, linearity, and robustness. Both drugs exhibited excellent linearity with correlation coefficients (r²) of 0.999. System suitability tests confirmed high performance with appropriate retention times and low tailing factors. Recovery studies at various concentration levels (80%, 100%, and 120%) showed high recovery rates with minimal deviation. Validation parameters, including repeatability, day-to-day variation, and analyst-to-analyst variation, demonstrated high precision with low % RSD values. The limit of detection (LOD) and limit of quantification (LOQ) were found to be sensitive, ensuring trace-level detection of both drugs. The method was successfully applied to the assay of tablet formulations, yielding assay values of 98.000% for DAPA and 99.300% for SITA. The results indicate that the developed HPLC method is suitable for routine quality control and stability studies of DAPA and SITA in pharmaceutical dosage forms.

Keywords: Dapagliflozin, Sitagliptin, HPLC, Linearity, System Suitability, Recovery Study, Validation.


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