Study on the Quality Control Standard of Lvxintong Rugao / 药学实践杂志

ABSTRACT

Objective To establish a quality control method for Lvxintong Rugao. Methods Ketoconazole, Halcinonide and Neomycin sulfate were identified by TLC. The content of Ketoconazole and Halcinonide were determined by HPLC. The chromatographic column of Agilent ZORBAX SB-C18 (4.6 mm×150 mm, 5 μm) column was used. Methanol-phosphate buffer (pH=7.40, 7525) was applied as the mobile phase. The detection wavelength was 235 nm. The flow rate was 1.0 ml/min and the column temperature was set at room temperature. Neomycin Sulfate was determined by polarimetric analysis. Results The identification and determination methods showed good specificity. Ketoconazole and Halcinonide displayed good linearity within the range of 1.999~39.98 μg (r=0.999 9) and 0.400 8~8.016 μg (r=0.999 9), respectively. The average recoveries were 97.75% (RSD 0.77%) and 97.57% (RSD 0.84%), respectively. For the determination of Neomycin Sulfate, r=0.999 6 (n=6) in the range of 130.4~2 608 U/ml (n=6). The precision and repeatability of RSD were 1.1% and 1.6%, respectively. The solutions were stable in 6 h and the average recovery was 98.8% (RSD 2.6%). Conclusion The method could be used as the quality control method for Lvxintong Rugao.