ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE BY RP-HPLC IN DRUG SUBSTANCE
Merugu Manasa* and Peddiboina Gopi
Abstract
A simple, accurate, precise and rapid Reversed-Phase High
Performance Liquid Chromatographic (RP-HPLC) method has been
developed and subsequently validated for the estimation of Metformin
Hydrochloride in pure form. The proposed method was separation of
Metformin by reversed-phase mode using SHISEIDO C-18 analytical
column (250×4.6 mm I.D., 5 μm particle size) and mobile phase
consisted of Acetonitrile: Phosphate buffer PH-7(50:50 v/v). Flow rate
of 1.0 ml/min and UV detection was set at 254 nm were selected peak
produced for Metformin Hydrochloride at retention time of 2.27 min.
The method was validated according to ICH guidelines. Linearity was obtained in the
concentration range of 10-35 μg/ml. Mean percent recovery of samples at each level for drug
was found in the range of 100.93%, %RSD was 1.47, LOD and LOQ were 0.011179 &
0.033876 respectively. By change in parameters like flow rate and temperature system
suitability parameters were within the limit, it indicates that the method was robust.
Keywords: Metformin Hydrochloride, HPLC, Method development, Validation, Acetonitrile, Phosphate buffer and C-18 column.
[Full Text Article]