Author(s): Lalit K Sahu, Sudam Si, Saroj Kumar Patro


DOI: 10.52711/0974-360X.2024.00177   

Address: Lalit K Sahu1*, Sudam Si1, Saroj Kumar Patro2
1School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan (Deemed to be University), Bhubaneswar 751003, Odisha, India.
2Institute of Pharmacy and Technology, Salipur, Cuttack - 754202, Odisha, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 3,     Year - 2024

The newly developed stability-indicating RP-HPLC method is simple, robust and validated on the basis of ICH guidelines for the simultaneous determination of Empaglifozin and Metformin hydrochloride in the tablet. Retention times under the optimized condition were 2.104 and 4.0822min for Metformin and Empaglifozin respectively. This research article indicates best separation of Empaglifozin and Metformin from their degradation products. Separation was achieved on a Sunniest ECO C18, 250mm x 4.6mm, 5µm analytical column at wavelength of 225nm, using a mobile buffer (pH-1.8): acetonitrile (50:50) in an isocratic elution mode at a flow rate of 1.2ml/min, Injection volume: 10µl and run time 6mins. The %RSDs for the precision studies was less than 1.5% for both drugs. The %RSD was less than 1.5% in all the parameters of robustness. The forced degradation studies were carried by using 0.1N HCl, 0.1 N NaOH and % 3 H2O2 and there is only % 7.2 degradation in an acidic medium for emplaglifozin and 11.63% for Meformin where as there was nothing degradation in basic and oxidative method. The analyte peaks were clearly separated from the degradant peaks in forced degradation studies. So this method is a fast, sensitive, robust and efficient high performance liquid chromatographic method for the concurrent determination of Metformin and Empaglifozin in their combination, and thus this method can be effectively employed for routine quality control works.

Cite this article:
Lalit K Sahu, Sudam Si, Saroj Kumar Patro. Stability Indicating Assay of Empaglifozin and Metformin. Research Journal of Pharmacy and Technology. 2024; 17(3):1135-4. doi: 10.52711/0974-360X.2024.00177

Lalit K Sahu, Sudam Si, Saroj Kumar Patro. Stability Indicating Assay of Empaglifozin and Metformin. Research Journal of Pharmacy and Technology. 2024; 17(3):1135-4. doi: 10.52711/0974-360X.2024.00177   Available on:

1.    Chawla G, Chaudhary KK. A complete review of empagliflozin: Most specific and potent SGLT2 inhibitor used for the treatment of type 2 diabetes mellitus, Diabetes and Metabolic Syndrome. Clinical Research and Reviews 2019; 13(3): 2001-08.
2.    Ruisheng Song. Mechanism of Metformin: A Tale of Two Sites. Diabetes Care. 2016; 39(2): 187–189,
3.    Inzucchi SE, Zinman B, Fitchett D, Wanner C, Ferrannini E, Schumacher M, Schmoor C, Ohneberg K, Johansen OE, George JT, Hantel S, Bluhmki E, Lachin JM. How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG Outcome Trial. Diabetes Care. 2018; 41: 356–63. DOI: org/10.2337/dc17-1096
4.    Tentolouris A, Vlachakis P, Tzeravini E, Eleftheriadou I, Tentolouris N, SGLT2 Inhibitors: A Review of Their Antidiabetic and Cardioprotective Effects. Int. J. Environ. Res. Public Health 2019; 16: 1-27,
5.    International non-proprietary name: empagliflozin / metformin, 26 March 2015 EMA/238334/2015 Committee for Medicinal Products for Human Use (CHMP)
6.    Biscaino PT, Christ AP, Librelotto DRN, Rolim CMB, Adamsi AIH. Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples. Brazilian Journal of Pharmaceutical Sciences Braz. J. Pharm. Sci. 2021; 57. doi: org/10.1590/s2175-97902020000418903
7.    Munde MkK, Kulkarni NS, Khiste RH, Sen DB. Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy. Research J. Pharm. and Tech. 2020; 13(3): 1236-42. DOI: 10.5958/0974-360X.2020.00228.0
8.    Sushil D. Patil, Sayali K. Chaure, Sanjay Kshirsagar. Development and validation of UV spectrophotometric method for Simultaneous estimation of Empagliflozin and Metformin hydrochloride in bulk drugs. Asian J. Pharm. Ana. 2017; 7(2): 117-123. doi: 10.5958/2231-5675.2017.00019.9
9.    Manoe JW, Primieri GB, Bueno L´M, Wingert NR, Volpato NM, Garcia CV, Schapoval EES, Steppe M. The application of quality by design in the development of the liquid chromatography method to determine empagliflozin in the presence of its organic impurities. RSC Adv. 2020; 10: 7313–20, DOI: 10.1039/c9ra08442h
10.    Thakor NS, Amrutkar SV, Chaudhari PD. Simultaneous Estimation of Empagliflozin and Metformin by High-Performance Thin-Layer Chromatography Using Quality-by-Design Approach. JPC – Journal of Planar Chromatography – Modern TLC. 2019; 32: 295–307, DOI: org/10.1556/1006.2019.32.4.4
11.    International Conference on Harmonization (ICH). Validation of Analytical Procedures: Text and Methodology Q2 (R1). Geneva; 2005.
12.    Lloyd RS, Joseph JK and Joseph LG, Practical HPLC method development, John Wiley and Sons, Inc. USA, 1997, 686-689.
13.    Munde MKK, Kulkarni NS, Sen AK, Sen DB. A Novel Validated Stability Indicating Analytical Method for Simultaneous Quantification of Metformin Hydrochloride and Empagliflozin in Bulk and Marketed Formulation by HPTLC using Box-Wilson Experimental Design Approach. Indian Journal of Pharmaceutical Education and Research. 2020; 54(3): S644-S656, DOI: 10.5530/ijper.54.3s.164.
14.    Patil SD, Amurutkar SV, Upasani CD. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian Journal of Pharmaceutical Analysis. 2016; 6(4): 201- 206, DOI : 10.5958/2231-675.2016.00030.2
15.    Patel IM, Chhalotiya UK, Jani HD, Kansara D, Kachhiya HM, Shah DA. Simultaneous quantifcation of empaglifozin, linagliptin and metformin hydrochloride in bulk and synthetic mixture by RP–LC method. Future Journal Pharmaceutical Science. 2021; 7: 182, DOI: org/10.1186/s43094-021-00332-1.
16.    Bassam. MA, Mowaka S. LC/MS/MS Determination of Empagliflozin and Metformin. Journal of Chromatographic Science Pharmaceutical Chemistry. 2017; 55(7): 742-747, DOI: 10.1093/CHROMSCI/BMX030
17.    S. J. Daharwal, S Prakash Rao, Vijay Kumar Singh, Chandraprakash Dwivedi, Veena D. Singh. Comparative evaluation of marketed formulations of Metformin HCl. available in India. Asian J. Research Chem. 2015; 8(7): 441-444. doi: 10.5958/0974-4150.2015.00070.X
18.    Priya Barbude, Mukund Tawar, Prashant Burange. Method Development using a UV Visible Spectrophotometer for the Simultaneous Estimation of Metformin (MET), Saxagliptin (SXG), and Dapagliflozin (DGF) in Marketed Formulation. Asian Journal of Pharmaceutical Analysis. 2022; 12(4): 243-7. DOI: 10.52711/2231-5675.2022.00039
19.    Palaksha MN, Tamizh Mani T, Manjunatha E, G P Senthil Kumar. Comparative study of In-Vivo effects of Glipizide and Metformin HCl on plasma concentration of Aminophylline in healthy rabbits. Asian J. Pharm. Res. 2020; 10(2): 62-66. DOI: 10.5958/2231-5691.2020.00012.X
20.    Khushbu Patel, Ujashkumar A. Shah, Hirak V. Joshi, Jayvadan K. Patel, Chhaganbhai N. Patel. QbD Stressed Development and Validation of Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Linagliptin and Metformin HCl in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(5): 1917-3. doi: 10.52711/0974-360X.2022.00319
21.    Saroj Gajare, Vedantika Das, Ashwini Sambherao, Amar Zalte, Ravindra B. Saudagar. Development and Validation of Linagliptin and Metformin hydrochloride in Bulk and Combined Tablet Dosage Form by using UV Spectrophotometric Method. Asian J. Pharm. Ana. 2017; 7(2): 141-144. doi: 10.5958/2231-5675.2017.00022.9
22.    Hamid Khan, Mushir Ali, Alka Ahuja, Javed Ali. Validated UPLC/Q-TOF-MS Method for Simultaneous Determination of Metformin, Glimepiride and Pioglitazone in Human Plasma and its Application to Pharmacokinetic Study. Asian J. Pharm. Tech. 2017; 7(1): 27-32. DOI: 10.5958/2231-5713.2017.00005.8
23.    Gandla. Kumara Swamy, R. Lalitha, Ch. Mounika, B. Soumya, D. Sudheer Kumar. A Validated RP-HPLC Method for Simultaneous Determination of Metformin and Canagliflozin in Pharmaceutical Formulation. Asian J. Pharm. Ana. 2018; 8(2): 73-77. DOI: 10.5958/2231-5675.2018.00014.5
24.    Jajow Swapna, Chandaka Madhu, Mallepelli Srivani, M. Sumalatha, Y. Nehalatha, Y. Anusha. Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(3): 85-89.
25.    Vichare V S, Choudhari V P, M Venkat Reddy. Development and Validation of UV-Visible Spectroscopic Methods for Simultaneous Estimation of Canagliflozin and Metformin in Pharmaceutical Formulation. Asian J. Research Chem. 2019; 12(1): 16-20. doi: 10.5958/0974-4150.2019.00004.X

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