RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE STUDIES OF SODIUM-GLUCOSE CO-TRANSPORTER 2 (SGLT2) AND DIPEPTIDYL PEPTIDASE 4 (DPP-4) INHIBITORS EMPAGLIFLOZIN AND LINAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM.

Abstract

A fixed-dose amalgamation pill having linagliptin and empagliflozin, which includes a sodium-glucose co-transporter 2 (SGLT2) inhibitor as well as a dipeptidyl peptidase 4 (DPP-4) inhibitor correspondingly, has gained approval recently. This study presents a developed RP-HPLC technique for measuring Empagliflozin and Linagliptin in pharmaceutical preparations. The analytical method has validated for key characteristics, including linearity, precision, robustness, and accuracy, in accordance with the rules set by the ICH. The RP-HPLC analysis performed using an ODS column with measurements of 250 mm in length and 4.6 mm in diameter, and a 5 µm particle size. The mobile phase consisted of an ammonium acetate buffer (0.770 g per 1000 mL) as well as acetonitrile in a 65:35 (v/v) ratio, with a flow rate set at 1.00 mL/min. The detection has been carried out using a PDA detector. The optimal detection wavelengths were determined to be 210 nm for Empagliflozin and 290 nm for Linagliptin. For Empagliflozin, the calibration curve demonstrated tremendous linearity within the range of conc. for 20-120 µg/mL, having outstanding regression coefficient (R² = 0.9999). Similarly, Linagliptin exhibited linearity over a conc. range of 4.0 to 24 µg/mL, also having a regression coefficient of 0.9999. Limits of detection (LODs) for Linagliptin as well as Empagliflozin has proven at 0.313 µg/mL and 1.48 µg/mL, respectively. LOQs were discovered to be 4.48 µg/mL for Empagliflozin and 0.949 µg/mL for Linagliptin. Accuracy of Empagliflozin ranged from 98.60% to 100.12%, Linagliptin's accuracy ranged from 99.62% to 99.90%. It was discovered that every system suitability parameter fell between reasonable bounds.

This method is efficient, rapid, as well as suitable for use in (QCL) quality control laboratories to analyze Linagliptin and empagliflozin in solid dosage forms for pharmaceuticals.