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Method Development for Simultaneous Quantification of Anti-diabetic Drugs in Combined Solid Dosage Form: A Focus on
Shubham Sharma1, Rina Das1, Dinesh Kumar Mehta1
1M.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, HR, India.
Abstract:
Diabetes mellitus is a chronic metabolic disorder affecting millions worldwide, necessitating the effective management of blood glucose levels through anti-diabetic medications. Sulfonylureas and Biguanides, particularly Gliclazide, Glimepiride, Glipizide, Glibenclamide, and Metformin, are commonly used in combination therapies for improved glycemic control. Several methods, including UV spectrophotometry, high-performance liquid chromatography, high-performance thin-layer chromatography, micellar chromatography, and liquid chromatography-mass spectrometry, were assessed for their effectiveness. This study evaluates various analytical techniques employed to ensure the quality, efficacy, and safety of these formulations, under the ICH guidelines. RP-HPLC emerged as the most reliable technique, demonstrating superior sensitivity, precision, and linearity, with optimized retention times and low detection limits. LC-ESI-MS/MS exhibited the highest sensitivity, precision, and linearity, making it suitable for pharmacokinetic studies. Spectrophotometric and electrochemical methods provided cost-effective alternatives but lacked sensitivity. RP-HPLC and MS-based techniques can enhance data processing efficiency. These advancements will strengthen pharmaceutical quality control, ensure the safety and efficacy of anti-diabetic drug formulations, while optimizing therapeutic outcomes for diabetes management.
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