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Journal of Pharmaceutical Research

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RESEARCH ARTICLE New Validated UV Spectrophotometric Method for Simultaneous Marketed Brand Gibtulio Met (12.5/500mg) Fixed Dose Combination Tablets
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Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v23.4.99

Year: 2024, Volume: 23, Issue: 4, Pages: 242-245

Original Article

RESEARCH ARTICLE New Validated UV Spectrophotometric Method for Simultaneous Marketed Brand Gibtulio Met (12.5/500mg) Fixed Dose Combination Tablets

Shailesh B Patil1,∗, Jitendra D More2

1Department of Pharmaceutical Chemistry, DCS’s ARA College of Pharmacy, Nagaon, Dhule, University of KBC-NMU, Jalgaon, Maharashtra, India
2Department of Pharmaceutical Chemistry, Ravindra Nikam College of Pharmacy, Gondur, Dhule, University of KBC-NMU, Jalgaon, Maharashtra, India

*Corresponding Author
Email: [email protected]

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

A validated UV spectrophotometric method has been developed for the simultaneous quantification of Gibtulio Met (12.5/500mg) Fixed Dose Combination dosage forms using the simultaneous equation method. This approach is based on measuring the absorbance of Metformin HCl and Empagliflozin within the concentration ranges of 2-10 μg/ml and 0.1-5 μg/ml, respectively, at their respective λ max values of 235 nm and 225 nm. The linearity correlation coefficients for Metformin HCl and Empagliflozin in these concentration ranges were 0.999, and 0.9998 respectively. The results were statistically validated in compliance with ICH guidelines.

Keywords: Metformin, Empagliflozin, ICH guidelines

References

  1. Merck Index Online. Merck & Co, Whitehouse Station, NJ. Available from: https://merckindex.rsc.org/
  2. Sweetman SC. Martindale: The Complete Drug Reference. (pp. 1-3694) London. Pharmaceutical Press. 2009.
  3. Sen DB, Sen AK, Zanwar A, Balaraman R, Seth AK. Determination of Alogliptin benzoate and Metformin Hydrochloride in tablet dosage form by simultaneous equation and absorption ratio method. International Journal of Pharmacy and Pharmaceutical Sciences. 2015;7(8):380–383. Available from: https://journals.innovareacademics.in/index.php/ijpps/article/download/6953/6906/0
  4. Nair S, Wilding JPH. Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus. The Journal of Clinical Endocrinology & Metabolism. 2010;95(1):34–42. Available from: https://doi.org/10.1210/jc.2009-0473
  6. 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: characterisation and comparison with other SGLT-2 inhibitors. Diabetes, Obesity and Metabolism. 2012;14(1):83–90. Available from: https://doi.org/10.1111/j.1463-1326.2011.01517.x
  7. Frampton JE. Empagliflozin: a review in type 2 diabetes. Drugs. 2018;78(10):1037–1048. Available from: https://doi.org/10.1007/s40265-018-0937-z
  8. Padmaja N, Veerabhadram G. Method development and validation of RP-HPLC method for the estimation of Empagliflozin in API. International Journal of pharmaceutical sciences and research. 2016;7(2):724–727. Available from: https://doi.org/10.13040/IJPSR.0975-8232.7(2).724-27
  9. Kadam AT, Zameeruddin M, Arsul V. Development and validation of analytical methods for the simultaneous estimation of Metformin hydrochloride and Empagliflozin. Journal of Medical and Pharmaceutical Innovation. 2017;4(21):21–27.
  11. Ayoub BM, Emam RM, Youssef MM, Kattan MNE, Sayed MA, Kowider AM, et al. Mean centering method for determination of Empagliflozin and Metformin. Marmara Pharmaceutical Journal. 2017;21(3):669–674. Available from: https://doi.org/10.12991/marupj.323590
  13. Becket AH, Stenlake JB. Practical Pharmaceutical Chemistry. Fourth edition part two (Edition 4, Part 2). (pp. 284-286) New Delhi. CBS Publishers and Distributors. 1988.

Copyright

© 2024 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/) 

  • 18 February 2025

Year: 2024, Volume: 23, Issue: 4


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