A 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
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.
2. Tabish A Syed. Is diabetes becoming the biggest epidemic of twenty-first century? Int J Health Sci 2007;1:8-5.
3. Scheen JA. Pharmacokinetic and pharmacodynamic profile of Empagliflozin, a sodium glucose co-transporter 2 inhibitor. Clin Pharmacokinet 2014;53:225-13.
4. Shubrook JH, Bokaie BB, Adkins SE. Empagliflozin in the treatment of type 2 diabetes: evidence to date. Drug Des Dev Ther 2015;9:5803-793.
5. Raut SM, Maheswari A. Empagliflozin: novel antidiabetic and pro-cardiac drug. Indian J Anaesth 2017;61:440-1.
6. Nermeen A. Review on pharmacokinetics of empagliflozin, an inhibitor of the sodium-glucose cotransporter-2. Asian J Pharm Clin Res 2017;10:50-6.
7. Geetha SP, Lakshmana RK, Prasad KRS, Suresh BK. Development and validation of stability indicating reversed phase high-pressure liquid chromatography method for simultaneous estimation of metformin and empagliflozin in bulk and tablet dosage form. Asian J Pharm Clin Res 2016;9:126-35.
8. Padmaja N, Veerabhadram G. Method development and validation of RP-HPLC for the estimation of empagliflozin in API. Int J Pharm Sci Res 2016;7:727-4.
9. Madana Gopal N, Sridhar C. A validated stability indicating ultra-performance liquid chromatographic method for simultaneous determination of metformin hydrochloride and empagliflozin in bulk drug and tablet dosage form. Int J Appl Pharm 2017;9:45-50.
10. H Jaiswal Sushil, Katariyal MV, Katariyal V, R Katariya, GS Karva, Koshe Kishor. Validated stability Indicating RP-HPLC method for determination of process related impurities in Empagliflozin drug substances. World J Pharm Res 2017;6:1037-27.
11. Khalil A Ghadir. Salama Ismail, Gomaa S Mohammed, Helal A Mohammad. Validated PR-HPLC method for simultaneous determination of canagliflozin, dapagliflozin, empagliflozin and metformin. IJPCBS 2018;8:13-1.
12. Donepudi Sharmila, Achanta Suneeta. Validated HPLC-UV method for simultaneous estimation of Linagliptin and empagliflozin in Human plasma. Int J Appl Pharm 2018;10:56-61.
13. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1); 2005.
14. Geetha SA, Rajitha G, Ramya YY, Uma P. Analytical method development and validation of new stability-indicating reverse-phase high-performance liquid chromatography method for simultaneous estimation of metformin hydrochloride and empagliflozin in tablet dosage form. Asian J Pharm Clin Res 2019;12:241-4.
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