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

[摘要] 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.

[学科分类] 药理学