Author(s): Akanksha Dwivedi, Rajesh Sharma


DOI: 10.52711/0974-360X.2023.00612   

Address: Akanksha Dwivedi, Rajesh Sharma*
School of Pharmacy, D.A.V.V., Takshshila Campus, Khandwa Road, Indore - 4520001, Madhya Pradesh.
*Corresponding Author

Published In:   Volume - 16,      Issue - 8,     Year - 2023

For multicomponent pharmaceutical dosage forms, simultaneous equation method has emerged out as boon with lots of advantages like easy, rapid and sensitive method. In this study, a UV spectroscopic method has been established and authenticated for simultaneous estimation of Sitagliptin phosphate and Empagliflozin in bulk form. Methanol: Water (5:5) has been employed as common solvent for the proposed method. The optimum conditions for analysis of the drug were established. Sitagliptin phosphate and empagliflozin showed maximum absorbance (?max) at 267nm and 276.2nm respectively. The calibration plot was found to be linear in the range of 50-250µg/ml for sitagliptin phosphate and empagliflozin with R2= 0.9957 and 0.9981 respectively. Method was validated according to ICH guidelines for linearity, accuracy, precision, system suitability, robustness, sensitivity and specificity. The proposed method was simple, precise, sensitive, accurate, rapid and suitable for routine quality analysis of sitagliptin phosphate and empagliflozin in bulk.

Cite this article:
Akanksha Dwivedi, Rajesh Sharma. Development and Validation of Simultaneous Equation Method for Estimation of Sitagliptin Phosphate and Empagliflozin in bulk form by UV Spectroscopy. Research Journal of Pharmacy and Technology 2023; 16(8):3714-8. doi: 10.52711/0974-360X.2023.00612

Akanksha Dwivedi, Rajesh Sharma. Development and Validation of Simultaneous Equation Method for Estimation of Sitagliptin Phosphate and Empagliflozin in bulk form by UV Spectroscopy. Research Journal of Pharmacy and Technology 2023; 16(8):3714-8. doi: 10.52711/0974-360X.2023.00612   Available on:

1.    Indian Pharmacopoeia, Vol. 2, Govt. of India, Ministry of Health, Delhi, 2018 Sitagliptin Phosphate: pp.3926-3928.
2.    Herman GA, Bergman A, Liu F, et al. Pharmacokinetics and pharmacodynamic effects of the oral DPP-4 inhibitor sitagliptin in middle-aged obese subjects. Journal of Clinical Pharmacology. 2006 Aug; 46(8): 876-86. doi: 10.1177/0091270006289850.
3.    Kalra S. Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitors: A Review of Their Basic and Clinical Pharmacology. Diabetes Therapy.2014 Dec; 5(2): 355–366.doi: 10.1007/s13300-014-0089-4.
4.    Grempler R, Thomas L, Eckhardt M, Himmelsbach F, Sauer A, Sharp DE, et al.Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2)inhibitor: characterization and comparison with other SGLT-2 inhibitors. Diabetes Obesity and Metabolism. 2012 Jan; 14(1): 83-90. doi: 10.1111/j.1463-1326.2011.01517.x.
5.    El-Bagary RI, Elkady EF, Ayoub BM. Liquid chromatographic determination of sitagliptin either alone or in ternary mixture with metformin and sitagliptin degradation product, Talanta; 2011Apr, 85(1):673-680 DOI: 10.1016/j.talanta. 2011.04.0512011, 85, 673-680.
6.    Lange AD, Gasperin FT, dos Santos Passos C, Todeschini V, Volpato NM, Schapoval EE. Stability-indicating LC assay with determination of system suitability limits by a robustness test for sitagliptin in tablets and assessment of cytotoxicity for degradation products, Current Pharmaceutical Analysis. 2012; 8(4): 360-367.doi: 10.2174/157341212803341645
7.    Padmaja N. and Veerabhadram G. Method development and validation of RP-HPLC method for the estimation of empagliflozin in API, International Journal of Pharmaceutical Science and Research. 2016; Feb 7: 724-727. doi: 10.13040/IJPSR.0975-8232.7(2).724-27
8.    Attimarad M, Nagaraja SH, Aldhubaib BE, Nair A, VenugopalaK.N.:Simultaneous determination of metformin and three gliptins in pharmaceutical formulations using RP HPLC: application to stability studies on linagliptin tablet formulation, Pharmaceutical Research. 2014; Sep 48(4): 45-53. doi:10.5530/ijper.48.4.7
9.    Peraman R, Gowra CS, Padmanabha Reddy Y, Peruru KK. Stability-indicating RP-HPLC method for simultaneous determination of metformin hydrochloride and sitagliptin phosphate in dosage forms, Chromatographia. 2013; 76: 1153-1162.
10.    Bhende SD, Varanasi MB, Abbulu K, Divya Swetha M, Shravanthi V, Karuna Kumari J, et al. RP-HPLC method for the simultaneous estimation of sitagliptin phosphate and metformin hydrochloride in combined tablet dosage forms, Oriental Journal of Chemistry. 2012; Jan 28 (1): 463-469
11.    Shyamala, M. Soumika, E. Sangeetha, L. Mahender. Method development and validation of empagliflozin by rp-hplc in bulk and pharmaceutical dosage form. An International Journal of Advances in Pharmaceutical Sciences. 2016; Feb 7(1):3040-3042.
12.    Mounika P Siridevi, Hemant T Kumar, Srinivasa Y Rao, Vara Prasad K Rao. RPHPLC Method for Quantification of Empagliflozin in Pharmaceutical Formulation. Asian Journal of Pharmacy and Technology. Sep 2019; 9(3):208-211doi: 10.5958/2231-5713.2019.00035.7
13.    Alaa S, Amin SF, Mohamed MM. AboTaleb. Simultaneous For the Estimation of Metformin and Empagliflozin in Pharmaceutical Dosage Form by HPLC Method. IOSR Journal of Pharmacy and Biological Sciences. 2019; Feb14(1): 75-80
14.    Madhusudhan P, Radhakrishna MR, Devanna N. RPHPLC Method Development and Validation for Simultaneous Determination of Linagliptin and Empagliflozin in Tablet Dosage Form. International Advanced Research Journal in Science, Engineering and Technology. 2015; Dec2(2): 95-99.doi: 10.17148/IARJSET
15.    Potdar A, Jorige A, Mogili S. Development and validation of uv spectrophotometric method for simultaneous estimation of empagliflozin and metformin hydrochloridein combined dosage form. International Journal of Pharmaceutical Sciences and Research. 2020; May 11(5): 2173-2180.10.13040/IJPSR.0975-8232.11(5).2173-80
16.    Davidson, AG, In: Beckette, AH and Stenlake, JB, Eds., Practical Pharmaceutical Chemistry, 4thEdn., Vol. II, CBS Publishers and Distributors, New Delhi, 2002, 284.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

56th percentile
Powered by  Scopus

SCImago Journal & Country Rank

Recent Articles


Not Available