用RP-HPLC法测定盐酸林可霉素眼用温敏凝胶中盐酸林可霉素的含量

目的:建立RP-HPLC法测定盐酸林可霉素眼用温敏凝胶中盐酸林可霉素的含量。方法:采用Diamond C18色谱柱(250mm×4.6mm,5μm),流动相:0.05mol/L硼砂溶液(用磷酸调节pH至7.4)-甲醇(50∶50),流速:1.0ml/min,检测波长:214nm。结果:盐酸林可霉素在2～48μg/ml范围内线性关系良好(r=0.999 9),日内和日间精密度、稳定性、重复性良好,低、中、高浓度(11.608、17.584、41.501μg/ml)的加样回收率分别为(91.40±1.27)%、(97.55±0.93)%和(99.13±1.11)%(n=3)。3批样品中盐酸林可霉素的平均含量分别为标示量的(98.67±1.21)%、(99.90±0.44)%和(99.28±1.17)%(n=3)。结论:该方法准确、灵敏,重现性好,可用于盐酸林可霉素眼用温敏凝胶的含量测定。

Determination of the lincomycin hydrochloride content in lincomycin hydrochloride thermosensitive eye gel by RP-HPLC method

Objective:To establish a RP-HPLC method for determination of the lincomycin hydrochloride content in lincomycin hydrochloride thermosensitive eye gel.Methods:The separation was performed on a Diamond C18 column(250 mm×4.6 mm,5 μm) with the mobile phase consisting of 0.05 mol/L borax water solution(pH value adjusted to 7.4 by phosphoric acid)-methanol(50∶50) at the flow rate of 1.0 ml/min.The detection wavelength was 214 nm.Results:Lincomycin hydrochloride presented a good linearity within the range of 2-48 μg/ml(r=0.999 9).It had good intra-and inter-day precision,stability and reproducibility.The average recovery rates of low,middle and high concentrations(11.608,17.584,41.501 μg/ml) were(91.40±1.27)%,(97.55±0.93)% and(99.13±1.11)%(n=3),respectively.The average contents of lincomycin hydrochloride in three batches of samples were(98.67±1.21)%,(99.90±0.44)% and(99.28±1.17)%(n=3),respectively.Conclusion:It is an accurate,sensitive and reproducible method for determination of the lincomycin hydrochloride content in lincomycin hydrochloride thermosensitive eye gel.