EMPAGLIFLOZIN: RP-HPLC BASED ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Yogeshwari Jambhulkar*, Nitu Madan and Pratik Mate

ABSTRACT

The investigation focuses on developing an efficient analytical method for the quantification of empagliflozin in pharmaceutical dosage forms, as there is currently no pharmacopoeial method available for the drug. The newly developed method was validated following ICH guidelines. A C18 column was used for analysis, with a mobile phase consisting of 0.1% trifluoroacetic acid solution and acetonitrile in a 70:30 (v/v) ratio at pH 4.8. The method demonstrated a highly linear calibration curve (r² > 0.999) over a concentration range of 0.025 to 30μg/mL The limits of detection (LOD) and quantification (LOQ) were found to be 0.020 μg/mL and 0.061 μg/mL, respectively. Recovery studies showed excellent accuracy, with recovery values ranging from 98.0% to 100.13%. The precision and accuracy of the method were within 2%, confirming its suitability for routine pharmaceutical analysis. The stability of the drug solution was tested at both refrigerated and ambient room temperatures, with mean accuracy above 98%. The method was applied to quantify empagliflozin in raw API and tablet formulations, yielding mean assay values for raw empagliflozin ranging from 99.29% ± 1.12 to 100.95% ± 1.69, and for tablet brands ranging from 97.18% ± 1.59 to 98.92% ± 1.00. These findings demonstrate that the developed method is reliable and accurate for the quantification of empagliflozin in both raw and pharmaceutical dosage forms.

Keywords: Bulk dosage form, empagliflozin, HPLC, method development, validation.