A RAPID AND SENSITIVE RP-HPLC METHOD FOR THE QUANTITATIVE ANALYSIS OF EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM: Quantification of Empagliflozin in pharmaceutical formulations by RP HPLC

MADHURIMA BASAK; Santhosh Reddy Gouru; Animesh Bera; Krishna veni Nagappan

doi:10.22159/ijap.2019v11i5.33281

Authors

MADHURIMA BASAK Department of Pharmaceutical Analysis, JSS College of Pharmacy, Ooty, (A Constituent College-JSS Academy of Higher Education and Research), Tamilnadu, India
Santhosh Reddy Gouru Department of Pharmaceutical Analysis, JSS College of Pharmacy, Ooty, (A Constituent College-JSS Academy of Higher Education and Research), Tamilnadu, India
Animesh Bera Department of Pharmaceutical Analysis, JSS College of Pharmacy, Ooty, (A Constituent College-JSS Academy of Higher Education and Research), Tamilnadu, India
Krishna veni Nagappan Department of Pharmaceutical Analysis, JSS College of Pharmacy, Ooty, (A Constituent College-JSS Academy of Higher Education and Research), Tamilnadu, India

DOI:

https://doi.org/10.22159/ijap.2019v11i5.33281

Keywords:

Empagliflozin, RP-HPLC, Method Optimization, Method Validation

Abstract

Objective: The present study aims at developing an accurate precise, rapid and sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for assessing Empagliflozin in bulk drug and in the pharmaceutical dosage form.

Methods: The proposed method employs a Reverse Phase Shim Pack C₁₈ column (250 mm × 4.6 mm id; 5 µm) using a mobile phase comprising of acetonitrile and water in the ratio of 60:40 v/v flushed at a flow rate of 1 ml/min. The eluents were monitored at 223 nm.

Results: Empagliflozin was eluted at a retention time of 5.417 min and established a co-relation co-efficient (R²>0.999) over a concentration ranging from 0.0495-100µg/ml. Percentage recovery was obtained between 98-102% which indicated that the method is accurate. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found at 0.0125µg/ml and 0.0495µg/ml, respectively.

Conclusion: An RP-HPLC method which was relatively simple, accurate, rapid and precise was developed and its validation was performed for the quantitative analysis of empagliflozin in bulk and tablet dosage form (10 and 25 mg) in accordance to International Conference of Harmonization (ICH) Q2 (R₁) guidelines. The proposed method may aid in routinely analyzing empagliflozin in pharmaceuticals.

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