HPLC法测定盐酸克林霉素胶囊中的克林霉素亚砜  

HPLC determination of clindamycin sulfoxide in clindamycin hydrochloride capsules

作　　者：蒋蒨 周旭 李荣 谭茂兰 邓安勇 JIANG Qian;ZHOU Xu;LI Rong;TAN Maolan;DENG Anyong(Chongqing Kerui Pharmaceutical(Group)Co.,LTD.,Chongqing 400060,China)

机构地区：[1]重庆科瑞制药(集团)有限公司,重庆400060

出　　处：《中国药品标准》2023年第6期631-635,共5页Drug Standards of China

摘　　要：目的:建立高效液相色谱法测定盐酸克林霉素胶囊中克林霉素亚砜的含量。方法:采用Agilent HC-C_(18)(4.6 mm×250 mm,5μm);流动相为0.05 mol·L^(-1)磷酸二氢钾溶液(用25%氢氧化钾溶液调pH至7.5)-乙腈(55∶45);流速1.0 mL·min^(-1);检测波长210 nm;柱温40℃;进样体积20μL。结果:克林霉素亚砜和相邻色谱峰之间的分离度良好,克林霉素亚砜的定量限为1.74 ng,检测限为0.52 ng,在0.086 51~17.30μg·mL^(-1)浓度范围内线性良好(r=0.999 9),平均回收率为98.79%,RSD为0.66%(n=6)。测定结果显示,克林霉素亚砜在克林霉素胶囊中的含量较低,仅在3批制剂中检出(0.01%),其余3批未检出。结论:该法可用于盐酸克林霉素胶囊中对杂质克林霉素亚砜的控制。Objective:To establish a high-performance liquid chromatography method for the determination of clindamycin sulfoxide in clindamycin hydrochloride capsules.Methods:The HPLC method parameters were as follows,Agilent HC-C_(18 )(4.6 mm×250 mm,5 μm),0.05 mol·L~(-1) potassium dihydrogen phosphate solution(pH adjusted to 7.5 with 25% potassium hydroxide solution)-acetonitrile=55∶45 as a mobile phase,flow rate of 1.0 mL·min~(-1),detection wavelength of 210 nm,column temperature of 40 ℃,and injection volume of 20 μL.Results:The resolution between clindamycin sulfoxide and its adjacent chromatographic peaks was satisfactory.The quantification limit and detection limit of clindamycin sulfoxide were 1.74 ng and 0.52 ng,respectively,and calibration curve showed good linearity in the range of 0.09-17.30 μg·mL~(-1)(r=0.999 9),with the average recovery of 98.79%(RSD=0.66%,n=6).The results showed that the content of clindamycin sulfoxide in clindamycin hydrochloride capsules was low,only detected in three batches of capsules(0.01%),and not detected in other three batches of capsules.Conclusion:The HPLC method is suitable for the determination of clindamycin sulfoxide in clindamycin hydrochloride capsules.

关 键 词：盐酸克林霉素胶囊 克林霉素亚砜 林可酰胺类抗生素 广谱抗菌 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]