STABILITY-INDICATING HPLC METHOD FOR DETERMINATION OF VANCOMYCIN HYDROCHLORIDE IN THE PHARMACEUTICAL DOSAGE FORMS.
STABILITY-INDICATING HPLC METHOD FOR DETERMINATION OF VANCOMYCIN HYDROCHLORIDE IN THE PHARMACEUTICAL DOSAGE FORMS.
复制标题
用于测定药物剂型中盐酸万古霉素的稳定性指示 HPLC 方法。
DOI：
--
复制
发表时间：
2017
期刊：
影响因子：
--
通讯作者：
A. Zarghi
中科院分区：
文献类型：
--
作者：
A. Serri;Hamid Reza Moghimp;A. Mahboubi;A. Zarghi
建立了一种简便、快速、选择性强的反相高效液相色谱法测定盐酸万古霉素的含量。采用Capital C8-Optimal色谱柱（250 × 4.6 mm，粒径为5 μm），流动相为缓冲柠檬酸盐（pH 4）、乙腈和甲醇，体积比为85:10:5。流动相采用等压高效液相色谱系统泵送，流速为1 mL/min，分析物的定量基于在280 nm处测量其峰面积。以一水头孢氨苄作为内标。盐酸万古霉素和头孢氨苄的保留时间分别为4.30和7.50。从线性、范围、精密度、准确度、特异性和检出限等方面验证了该方法的可靠性。在1 ~ 100 μg/mL范围内线性良好，相关系数为0.9999。通过对强制降解（水解、氧化、热分解和光解）产物的分析，证明了该方法具有选择性和稳定性。验证的高效液相色谱法可用于药品剂型中盐酸万古霉素的分析。降解产物是在国际统一会议（ICH）描述的压力降解条件下储存药物产生的。
A simple, rapid and selective RP-HPLC method was developed for the determination of vancomycin hydrochloride. The separation was achieved using a Capital C8-Optimal column (250 x 4.6 mm i.d., 5 μm particle size) with a mobile phase composed of buffer citrate (pH 4), acetonitrile and methanol in the ratio of 85 : 10: 5 (by volume), respectively. The mobile phase was pumped using an isocratic HPLC system at a flow rate of I mL/min and quantification of analyte was based on measuring its peak areas at 280 nm. Cephalexin monohydrate was used as internal standard (IS). The retention times for vancomycin hydrochloride and cephalexin were about 4.30 and 7.50, respectively. The reliability of the proposed HPLC procedure was validated with respect to linearity, ranges, precision, accuracy, specificity and detection limit. Calibration curve was linear in the ranges of 1-100 μg/mL with correlation coefficient of 0.9999. The proposed method proved to be selective and stability-indicating by the resolution of the analytes from the forced degradation (hydrolysis, oxidation, thermolysis and photolysis) products. The validated HPLC method was successfully applied to the analysis of vancomycin hydrochloride in pharmaceutical dosage forms. The degradation products resulted from the storage of the drug under stress degradation conditions described by the International Conference on Harmonisation (ICH).