Determination of gentamicin C components in gentamicin sulfate granules by the column-switching HPLC-ELSD method
Yao Yong-qing;Wang Li-ping;Liu Ying;Henan Provincial Institute of Food and Drug Control;
Objective To establish the column-switching HPLC-ELSD method for determination of gentamicin C components in gentamicin sulfate granules, and 190 batch samples from national drug plan were tested. Methods High performance liquid chromatograph with switching six-way valve was used. The column was Apollo C_(18)(250 mm×4.6 mm, 5μm), the mobile phase was 0.2 mol/L trifluoroacetic acid solution: methanol(96:4), the column temperature was 35℃, the flow rate was 0.6 mL/min, and the injection volume was 25μL. The ELSD: Drift tube temperature was 110℃, the carrier gas flow rate was 2.5 L/min, and the gain was 1. Results The interference of sucrose as excipient was effectively removed by the newly established column-switching HPLC-ELSD method. The average recoveries of gentamicin C components(C_1, C_(1a), C_2 and C_(2a)) were 98.9%, 102.0%, 100.1%, and 98.6%. RSD(n=9) were 0.5%, 0.4%, 0.3% and 0.6%, respectively. The linear ranges were 0.0517～0.6465, 0.0538～0.6729, 0.0651～0.8136 and 0.0299～0.3738 mg/mL, respectively. The content of gentamicin C_1 was lower in 12 batches, the content of total C component of gentamicin was lower in 2 batches and was higher in 3 batches. Conclusion The new method is accurate, simple and specific. It can provide reference for the control of gentamicin C in gentamicin sulfate granules.
【CateGory Index】： O657.72;TQ465