Determination and Method Validation for Metformin Hydrochloride Drug Content from Pharmaceutical Product by Reversed Phase High Performance Liquid Chromatography.

Research Article

Raju Chandra, Harchan Singh an

Abstract

Reversed phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of metformin hydrochloride from marketed tablets. Chromatographic Separation of metformin hydrochloride has been done with C18 column. The mobile phase methanol-water was used in the ratio 70:30 (v/v). The HPLC instrument was equipped with dual pump and UV-VIS detector. The active ingredient of the drug content metformin hydrochloride was optimized at 216 nm. Drug content was determined at the flow rate 1.0 mL/min. The retention time of analyte was 6.38 min. The linearity range was 5-100 μg/mL. The linearity of the method was obtained (R2=0.997). The limit of detection (LOD) and limit of quantification (LOQ) were calculated to be 0.03 and 0.09 μg/mL, respectively. The recoveries of the drug content were found at the three concentration level 99.80, 99.90 and 99.80 %, respectively. Hence, all these results shown that the method validation can be used for routine analysis.

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