Pharmacovigilance guidelines serve as essential frameworks and standards that govern the practice of pharmacovigilance globally. These guide
Pharmacovigilance guidelines serve as essential frameworks and standards that govern the practice of pharmacovigilance globally. These guidelines provide guidance and recommendations for various stakeholders involved in drug safety monitoring, including regulatory authorities, pharmaceutical companies, healthcare professionals, and researchers.
Analytical Method Development and Validation of Metformin Hydrochloride by using RP HPLC with ICH Guidelines
by Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure" Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines"
Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3 , April 2019,
Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/22812/analytical-method-development-and-validation-of-metformin-hydrochloride-by-using-rp-hplc-with-ich-guidelines/mr-nilesh-nikam
call for paper chemistry, ugc approved journals for chemistry, chemistry journal
A simple and reproducible method was developed for Metformin MET by Reverse Phase High Performance Liquid Chromatography RP HPLC. Metformin was separated on C18 column 4.6x250mm, particle size 5µm, using combination of phosphate buffer with pH of 3.0 and Methanol at the UV detection of 238nm. Isocratic elution of phosphate buffer with pH of 3.0 and Methanol was used as a mobile phase with various ratios and flow rates, eventually 30 70 v v phosphate buffer with pH of 3.0 and Methanol was being set with the flow rate of 1mL min. The statistical validation parameters such as linearity, accuracy, precision, inter day and intra day variation were checked, assay studies of Metformin were within 98 to 102 indicating that the proposed method can be adoptable for quality control analysis of Metformin.
