Serri Azadeh, Moghimp Hamid Reza, Mahboubi Arash, Zarghi Afshin
Acta Pol Pharm. 2017 Jan;74(1):73-79.
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).
建立了一种简单、快速且选择性好的反相高效液相色谱法（RP-HPLC）用于测定盐酸万古霉素。采用Capital C8-Optimal色谱柱（250×4.6 mm内径，5μm粒径）进行分离，流动相由柠檬酸缓冲液（pH 4）、乙腈和甲醇按体积比85:10:5组成。使用等度高效液相色谱系统以1 mL/min的流速泵入流动相，基于在280 nm处测量分析物的峰面积对其进行定量。头孢氨苄一水合物用作内标（IS）。盐酸万古霉素和头孢氨苄的保留时间分别约为4.30和7.50。所提出的高效液相色谱法的可靠性在线性、范围、精密度、准确度、特异性和检测限方面得到了验证。校准曲线在1-100μg/mL范围内呈线性，相关系数为0.9999。通过将分析物与强制降解（水解、氧化、热解和光解）产物分离，证明所提出的方法具有选择性且能指示稳定性。经验证的高效液相色谱法成功应用于药物剂型中盐酸万古霉素的分析。降解产物是由药物在国际协调会议（ICH）描述的加速降解条件下储存产生的。
