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VOL. 10, ISSUE 4 (2025)
A review on RP-HPLC and related analytical methodologies for the simultaneous estimation of Sitagliptin Phosphate Monohydrate, Gliclazide, and Metformin Hydrochloride in pharmaceutical dosage forms
Authors
Amisha Bhoya, Joshi Pooja, Dr. Dipti B Patel, Dr. Deepa Patel, Dr. Ghanshyam Patel
Abstract
Type-2 diabetes mellitus (T2DM) is a
multifactorial metabolic disorder requiring poly-drug therapy for glycemic
control. Combination regimens containing Sitagliptin Phosphate Monohydrate (a
DPP-4 inhibitor), Gliclazide (a sulfonylurea) and Metformin Hydrochloride (a
biguanide) are extensively prescribed because of complementary mechanisms of
action. Analytical evaluation of these agents—alone and in mixtures—is
essential for ensuring product quality, therapeutic
equivalence, and regulatory compliance.
This review summarizes official and non-official analytical methodologies reported for these three antidiabetic drugs in bulk, formulations, and biological matrices. Emphasis is placed on RP-HPLC, HPTLC, UV-spectrophotometric, UPLC, and LC-MS/MS techniques; method validation according to ICH Q2 (R1); and in-vitro dissolution assessment. Information from patents and peer-reviewed articles (2010–2025) has been consolidated to provide a comprehensive view of current trends and regulatory perspectives.
The review highlights the significance of chromatographic optimization, greenness assessment, and analytical-quality-by-design (AQbD) tools in developing robust and eco-friendly methods for simultaneous estimation of multi-component antidiabetic dosage forms.
This review summarizes official and non-official analytical methodologies reported for these three antidiabetic drugs in bulk, formulations, and biological matrices. Emphasis is placed on RP-HPLC, HPTLC, UV-spectrophotometric, UPLC, and LC-MS/MS techniques; method validation according to ICH Q2 (R1); and in-vitro dissolution assessment. Information from patents and peer-reviewed articles (2010–2025) has been consolidated to provide a comprehensive view of current trends and regulatory perspectives.
The review highlights the significance of chromatographic optimization, greenness assessment, and analytical-quality-by-design (AQbD) tools in developing robust and eco-friendly methods for simultaneous estimation of multi-component antidiabetic dosage forms.
Pages:60-61
How to cite this article:
Amisha Bhoya, Joshi Pooja, Dr. Dipti B Patel, Dr. Deepa Patel, Dr. Ghanshyam Patel "A review on RP-HPLC and related analytical methodologies for the simultaneous estimation of Sitagliptin Phosphate Monohydrate, Gliclazide, and Metformin Hydrochloride in pharmaceutical dosage forms". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 10, Issue 4, 2025, Pages 60-61
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