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HPLC determination of the related substances of phenformin hydrochloride

WANG Ben-xiao£¬ZHU Hai-yan,DING Jie

(Shandong Institute of Pharmaceutical Industry£¬Jinan£¬250100)



Abstract  Objective:To establish an HPLC method for determination of the related substances of phenformin hydrochloride.Methods:The separation was performed on a Phenomenex-ODS-C18column£¨250 mm¡Á4.60 mm£¬5 ¦Ìm£©.The mobile phase was composed of methanol-10 mmol¡¤L-1sodium dodecylsufonate in 5 mmol¡¤L-1 potassium dihydrogen phosphate (previously adjusted to pH 3.5¡À0.05 with phosphoric acid)(72¡Ã28).The flow rate was 1.0 mL¡¤min-1.The detection was carried out with a diode array detector at 216 nm.Column temperature was at room temperature.Results:The calibration curve of phenformin hydrochloride was linear between 3 to 300 ¦Ìg¡¤mL-1 (r=0.9999),the detection limit was 0.5 ng with RSD of 0.4%(n=6);The calibration curve of dicyandiamide was linear between 0.05-0.3 ¦Ìg¡¤mL-1(r=0.9999),the detection limit was 0.15 ng with RSD of 0.6%(n=6).Conclusion:The method is simple and accurate with good sensitivity and reproducibility.It can be used for the quality control of phenformin hydrochloride.

Key words£ºphenformin hydrochloride£»HPLC£»related substances


http://www.nicpbp.org.cn/cmsweb/webportal/W361/A2337.html
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