Quantitative Estimation and Validation of Metformin Hydrochloride and Gliclazide in their Tablet Dosage Form by RP-HPLC Shinde Ganesh S1,*, Rahul K Godge1, Dr Jadhav Ravindra2 1Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.-Ahmednagar 2Department of Pharmacognosy, Pravara Rural College of Pharmacy, Pravaranagar. Tal-Rahata, Dist.-Ahmednagar *Corresponding Author E-mail: shinde.ganesh904@gmail.com
Online published on 31 December, 2019. Abstract A rapid and sensitive isocratic reversed phase high performance liquid chromatographic method has been developed for quantitative analysis of metformin hydrochloride and gliclazide in bulk as well as pharmaceutical dosage forms. The method was validated according to FDA, ICH and USP guidelines with respect to accuracy, precision, specificity and linearity. The method was developed by using the mobile phase comprising of methanol and water (80: 20) at a flow rate of 0.9 mL/min over Grace C18 (250mm x 4.6ID, Particle size: 5 micron) at ambient temperature. The retention time obtained for gliclazide and metformin was 5.3and 3.4min respectively. The recovery was found to be more than 97% for metformin and 102% for gliclazide that demonstrated the accuracy of the protocol. Intraday and interday precisions of the new method were less than the maximum allowable limit (% RSD 2.0) specified by the ICH and FDA. The proposed RP-HPLC method is sensitive, precise and accurate. Top Keywords Metformin, Gliclazide, RP-HPLC, Validation. Top |