林可霉素-大观霉素复方混悬注射液中有效成分含量的HPLC法测定

Assay of Lincomycin and Spectinomycin in Oily Injectable Suspensions by HPLC

建立了测定林可霉素-大观霉素复方油混悬注射液中盐酸林可霉素与盐酸大观霉素含量的高效液相色谱(HPLC)方法。采用C18色谱柱(4.6 mm×250 mm,5μm),检测林可霉素的流动相为0.05mol/L硼砂溶液(用850 mL/L磷酸调节pH至5.0)-甲醇-乙腈(60∶36∶4),检测波长为214 nm;检测大观霉素的流动相为乙腈-四氢呋喃-水(30∶35∶35),检测波长为415 nm。结果表明,在10μg/mL^40μg/mL浓度范围内,林可霉素和大观霉素均呈良好线性关系,二者平均回收率分别为98.68%和99.10%,平均批内变异系数分别为0.93%和0.86%,批间变异系数分别为1.68%和0.98%。本方法操作简便、准确,可用于林可霉素-大观霉素复方油混悬注射液含量的测定。

A high-performance liquid chromatographic（HPLC） method with ultraviolet-visible detection was developed to measure the concentrations of lincomycin and spectinomycin in their oily injectable suspensions.The separation was performed on a C18 column（4.6 mm×250 mm,5 μm）,the mobile phase of lincomycin comprised of 0.05 mol/L borax solution（pH5.0,adjusted with 85% phosphoric acid）-methanol-acetonitril（60∶36∶4）,UV detection was set at a wavelength of 214nm.the mobile phase of spectinomycin comprised of acetonitril,tetrahydrofuran and water（30∶35∶35）,UV detection was set at a wavelength of 415 nm.The standard curves of lincomycin and spectinomycin were linear in the range between 10 μg/mL to 40 μg/mL,rthe average recoveries were 98.68% for lincomycin and 99.10% for spectinomycin,the average intraassay coefficients of variation were 0.93% for lincomycin and 0.86% for spectinomycin,and the interassay coefficients of variability were 1.68% and 0.98%,respectively.The present method was precise and convenient,and could therefore be used to quantify lincomycin and spectinomycin in oily injectable suspensions.