Development of Validated RP-HPLC Method for Estimation of Empagliflozin and Metformin in Combined Formulation
Vichare Vijaya *
PES Modern College of Pharmacy (For Ladies), Moshi, Pune, Maharashtra, India.
Kandekar Ujjwala
JSPM’s Rajashri Shahu College of Pharmacy and Research, Tathawade, Pune, Maharashtra, India.
Dhaware Pallavi
ADT’s, Sharadabai Pawar Institute of Pharmaceutical Sciences and Research, Sharda Nagar, Baramati, Maharashtra, India.
V. P. Choudhari
School of Pharmacy, MIT World Peace University, Pune, Maharashtra, India.
*Author to whom correspondence should be addressed.
Abstract
Aim: The aim of the present study include development of validated RP-HPLC method for estimation of Empagliflozin and Metformin in combined dosage form by using LC-MS compatible volatile mobile phase.
Methodology: Appropriate separation of drugs was achieved using C18 column as a stationary phase and Acetonitrile: Water (50: 50, v/v) at a flow rate 1mL/min as mobile phase. Detection was done at 230 nm.
Results: The Rt of Metformin and Empagliflozin was found to be 2.20 ± 0.02 min and 3.64 ± 0.02 min respectively. When the marketed formulation was analyzed by the developed method, the % drug contents were found to be 98.57 ± 1.28 and 99.86 ± 1.02 %w /w for Empagliflozin and Metformin, respectively. The method was found to be linear in a range of 11.25 – 56.25 μg/mL for Empagliflozin and 85 – 425 μg/mL for Metformin. Detection limit and quantitation limit were found to be 0.30 and 0.92 μg/mL for Empagliflozin and 1.12 and 3.36 μg/mL for Metformin, respectively. The accuracy and precision results were found to be near 100 % w/w for both the drugs. The method was also found to be robust and specific.
Conclusion: The developed RP-HPLC method was found to be linear, sensitive, accurate, precise, specific and robust for the analysis of Empagliflozin and Metformin in combined dosage form.
Keywords: Empagliflozin, metformin, RP-HPLC, Method validation