Empagliflozin: HPLC based analytical method development and application to pharmaceutical raw material and dosage...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• No official pharmacopoeial method exists for empagliflozin quantification.
• Accurate quantification is crucial for raw materials and pharmaceutical dosage forms.

Purpose of the Study:

• To develop and validate an efficient analytical method for empagliflozin.
• To enable routine quantification in pharmaceutical industries.

Main Methods:

• High-Performance Liquid Chromatography (HPLC) using a C18 column.
• Mobile phase: 0.1% trifluoroacetic acid and acetonitrile (70:30 v/v) at pH 4.8.
• Validation according to International Council for Harmonisation (ICH) guidelines.

Main Results:

• Excellent linearity (r² > 0.999) over 0.025-30 μg mL⁻¹.
• Low Limit of Detection (LOD) of 0.020 μg mL⁻¹ and Limit of Quantitation (LOQ) of 0.061 μg mL⁻¹.
• High accuracy (98.0-100.13% recovery) and precision (<2% variation).

Conclusions:

• The developed method is highly accurate, precise, and suitable for routine analysis.
• Empagliflozin was successfully quantified in raw API and marketed tablet forms.
• The method provides a reliable tool for quality control of empagliflozin products.