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Development and Validation of Stability Indicating Hplc Method for the Determination of Metformin Hydrochloride | Abstract
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Abstract

Development and Validation of Stability Indicating Hplc Method for the Determination of Metformin Hydrochloride

Author(s): Abd Elmagied DA, Abdalaziz T

A new simple, precise, accurate, selective and economical RP-HPLC method for assay of metformin hydrochloride was developed for determination of metformin hydrochloride. The method was carried out by using a stainless steel column L10 CN (250 cm × 4.6 mm × 5 µm), injection volume 20 µL, and flow rate of 1.0 mL per minute, a detection wavelength of 232 nm. The column oven temperature was 34°C and a mobile phase containing: acidified water (pH-3), acetonitrile (70:30 v/v). The retention time was 1.74 min and the tailing factor was 1.1. The developed method was validated according to international conference on harmonization for precision, accuracy, sensitivity, robustness and specificity. The linearity test showed a correlation coefficient of 0.9996. The LOD and LOQ were found to be 1.389 µg/ml and 4.2102 µg/ml, respectively. The intra-day and inter-day precision were found to be 0.0408 and 1.63, respectively.