Author(s):
Himanta Biswa Saikia, Bipul Nath, Junmoni Kalita, Payal Dasgupta, Bhaskar Jyoti Pathak, Pranabesh Sikdar
Email(s):
xaikiahimanta7@gmail.com
DOI:
10.52711/0974-360X.2026.00488 
Address:
Himanta Biswa Saikia1*, Bipul Nath2, Junmoni Kalita3, Payal Dasgupta4, Bhaskar Jyoti Pathak5, Pranabesh Sikdar6
1Department of Pharmaceutical Chemistry, Royal School of Pharmacy, The Assam Royal Global University, Guwahati, Assam - 781035, India. Orcid: https://orcid.org/0000-0003-4941-272X
2Department of Pharmaceutics, Royal School of Pharmacy, The Assam Royal Global University, Guwahati, Assam - 781035, India. Orcid: https://orcid.org/0000-0002-6018-0192
3Department of Pharmaceutical Chemistry, School of Pharmaceutical Sciences, Girijananda
Chowdhury University, Guwahati, Assam - 781017, India. Orcid: 0000-0002-5702-0796
4Department of Pharmaceutics, Royal School of Pharmacy, The Assam Royal Global University, Guwahati, Assam - 781035, India. Orcid: https://orcid.org/0000-0002-5982-7841
5Faculty of Pharmaceutical Science, Assam down town University, Sankar Madhab Path, Gandhi Nagar, Panikhaiti, Guwahati, Assam, 781026, India Orcid: 0000-0002-9330-9001
6Department of Phar
Published In:
Volume - 19,
Issue - 8,
Year - 2026
ABSTRACT:
A simple and rapid UV spectrophotometric method was developed and validated for the simultaneous estimation of metformin HCl, sitagliptin phosphate, and dapagliflozin monohydrate in their fixed-dose combination tablet formulations having good reproducibility and reliability. A simultaneous equation method approach is used with an isosbestic point at 258nm and a solvent system consisting potassium dihydrogen phosphate (KH2PO4) buffer and methanol. The developed method shows excellent linearity over the concentration ranges of 2–10µg/mL for dapagliflozin, 5–10µg/mL for sitagliptin, and 10–50µg/mL for metformin and a correlation coefficients value (R²) not less than 0.999 for all the samples. The method validation is followed according to ICH Q2(R1) guidelines, confirming it’s precision, accuracy, specificity and robustness. The recovery studies showed excellent values between 98% and 102%, and %RSD values remained in acceptable limits indicating high precision. The method shows low limits of detection (LOD) and quantification (LOQ) which exhibit high sensitivity. Specificity result shows no interference of excipients or degradation products. The robustness of the method was confirmed by small variations in analytical parameters which does not affect the result significantly. This rapid, cost-effective and reliable UV spectrophotometric method provides an alternat techniques then complex chromatographic techniques practically for routine analysis and quality control of triple-drug antidiabetic formulations, supporting regulatory compliance and effective diabetes management.
Cite this article:
Himanta Biswa Saikia, Bipul Nath, Junmoni Kalita, Payal Dasgupta, Bhaskar Jyoti Pathak, Pranabesh Sikdar. UV Spectrophotometric Method Development and Validation for the Simultaneous Quantification of Antidiabetic Drugs Metformin Hydrochloride Sitagliptin Phosphate and Dapagliflozin Monohydrate in their Fixed Dosage Combination Tablets. Research Journal of Pharmacy and Technology. 2026;19(8):3439-4. doi: 10.52711/0974-360X.2026.00488
Cite(Electronic):
Himanta Biswa Saikia, Bipul Nath, Junmoni Kalita, Payal Dasgupta, Bhaskar Jyoti Pathak, Pranabesh Sikdar. UV Spectrophotometric Method Development and Validation for the Simultaneous Quantification of Antidiabetic Drugs Metformin Hydrochloride Sitagliptin Phosphate and Dapagliflozin Monohydrate in their Fixed Dosage Combination Tablets. Research Journal of Pharmacy and Technology. 2026;19(8):3439-4. doi: 10.52711/0974-360X.2026.00488 Available on: https://rjptonline.org/AbstractView.aspx?PID=2026-19-8-5
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