Archive \ Volume.12 2021 Issue 4

RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation

Khagga Bhavyasri^1*, Thaneeru Surekha¹, Samreen Begum¹, Mogili Sumakanth¹

¹Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Affiliated to Osmania university, Barkatpura, Hyderabad, Telangana-500027, India.

Abstract

The given RP-HPLC technique was found to be clear-cut, specific, exact, and economical for estimation of Dapagliflozin and Metformin HCl in bulk and tablet dosage form. Stationary phase Phenomenex C18 250mm x 4.6 mm were utilized as chromatographic conditions. Water: Methanol in the ratio of 50:50 was used as fluid phase. The flow rate was maintained at 5 1.0ml/min, wave length of detection was 230 nm and diluent was water all maintained at a 30⁰C column temperature. As an optimized procedure, the conditions were finalized. By injecting the standard six times, apt system factors were studied and the outcomes were considerably below the acceptance criteria. Metformin HCl linearity was found to be 2-7 ppm and Dapagliflozin linearity was found to be 60-210 ppm with r²=0.999. For Dapagliflozin and Metformin HCl, precision value was found to be 0.8214% and 0.6342% respectively. For Dapagliflozin, LOD and LOQ values were found to be 345000 ppb and 415000 ppb respectively and for Metformin HCl LOD and LOQ values were found to be 263000 and 324000 ppb respectively. Assessment of the formulated market was carried out by using above method and percentage of Dapagliflozin and Metformin HCl was found to be 99.73 % and 99.85 % respectively.

Keywords: Dapagliflozin, Metformin, Liquid chromatography, Combined dosage forms, Simultaneous estimation