ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF EMPHAGLIFLOZIN BY RP-HPLC
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Abstract
Empagliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, is widely used in the management of type 2 diabetes mellitus (T2DM) due to its insulin-independent glucose-lowering mechanism and additional cardiovascular and renal benefits. Accurate and reliable quantification of Empagliflozin in pharmaceutical dosage forms is essential for quality control and regulatory compliance. This study aimed to develop and validate a simple, sensitive, cost-effective, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of Empagliflozin in bulk and tablet dosage forms, in accordance with ICH Q2(R1) guidelines. Chromatographic separation was achieved using a C18 column with a mobile phase of methanol and 0.05% acetic acid (75:25 v/v, pH 3.3–3.5) at a flow rate of 1.0 mL/min. Detection was performed at 224 nm. Method validation included assessment of specificity, linearity, accuracy, precision, sensitivity (LOD/LOQ), robustness, and stability-indicating capability through forced degradation studies. Sample and standard preparations followed validated protocols using marketed tablet formulations and reference-grade Empagliflozin. Empagliflozin exhibited a retention time of approximately 3.7–5.0 minutes. The method showed excellent linearity over the concentration range of 20–120 μg/mL (R² = 0.9995). Recovery studies confirmed high accuracy (99.0%–99.6%), and precision results demonstrated low %RSD (<0.5%) across intra- and inter-day evaluations. The LOD and LOQ were approximately 0.07 μg/mL and 0.35 μg/mL, respectively, indicating high sensitivity. Forced degradation studies under acidic, basic, oxidative, photolytic, and thermal conditions confirmed the method’s stability-indicating nature, with no interference from degradation products.The validated RP-HPLC method is accurate, precise, robust, and stability-indicating, making it highly suitable for routine quality control, stability testing, and regulatory submissions involving Empagliflozin in bulk and tablet forms. Its simplicity, rapid analysis time, and cost-effectiveness further support its application in pharmaceutical industry settings.
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