Abstract：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 C18 (250mm×4.6mm, 5μm), the mobile phase was 0.2mol/L trifluoroacetic acid solution: methanol(96:4), the column temperature was 35℃, the flow rate was 0.6mL/min, and the injection volume was 25μL. The ELSD: Drift tube temperature was 110℃, the carrier gas flow rate was 2.5L/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 (C1, C1a, C2 and C2a) 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 0.0299~0.3738mg/mL, respectively. The content of gentamicin C1 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.
姚永青 王立萍 刘英. 柱切换HPLC-ELSD法测定硫酸庆大霉素颗粒中庆大霉素C组分的研究[J]. 中国抗生素杂志, 2020, 45(06): 584-588.
Yao Yong-qing, Wang Li-ping and Liu Ying . Determination of gentamicin C components in gentamicin sulfate granules by the column-switching HPLC-ELSD method. CJA, 2020, 45(06): 584-588.