Content Determination of Bifonazole Gel from Different Manufacturers by HPLC
10.6039/j.issn.1001-0408.2016.15.34
- VernacularTitle:HPLC法测定不同厂家联苯苄唑凝胶的含量
- Author:
Yanmei QIAN
;
Minglan WU
;
Jie ZHENG
- Publication Type:Journal Article
- Keywords:
Bifonazole gel;
HPLC;
Content determination;
Commercially available products;
Quality
- From:
China Pharmacy
2016;27(15):2117-2118,2119
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To evaluate the quality of Bifonazole Gel from different manufacturers. METHODS:HPLC was per-formed on the column of Diamonsil C18 with mobile phase of methanol- water- tetrahydrofuran(75∶24∶1,V/V/V)at a flow rate of 1.0 ml/min,detection wavelength was 254 nm,column temperature was 23 ℃,and the injection volume was 10 μl. RESULTS:The linear range of bifonazole was 50-600 μg/ml (r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 97.71%-101.68%(RSD=1.16%,n=9). The contents of Bifonazole gel samples from 3 manufacturers were more than 10 mg/g,with little difference. CONCLUSIONS:The method is simple and accurate with good separation and re-producibility,and suitable for the content determination of Bifonazole gel. The investigated contents of products from different man-ufactures conform to relevant standards.