Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, 226031, UP, India.
Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India.
Bioanalysis. 2022 Jul;14(14):1005-1020. doi: 10.4155/bio-2022-0100. Epub 2022 Sep 6.
A novel HPLC method was developed and validated for the simultaneous estimation of paclitaxel (PTX) and baicalein (BAC). The analytes were resolved in a C18 column using the aqueous solution of formic acid (0.10% v/v) and MeOH (30:70 v/v). The developed method was found to be linear over the concentration ranges 0.039-10 μg/ml and 0.019-10 μg/ml for PTX and BAC, respectively. The lower limits of quantification obtained were 0.042 μg/ml and 0.361 μg/ml for PTX and BAC, respectively. The developed method was found to be precise and accurate as per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, for simultaneous estimation of PTX and BAC, having an application in formulation development and bioanalytical studies.
建立并验证了一种用于同时测定紫杉醇（PTX）和黄芩素（BAC）的新型 HPLC 方法。采用甲酸水溶液（0.10%v/v）和甲醇（30:70v/v）在 C18 柱上对分析物进行分离。结果表明，PTX 和 BAC 的浓度范围分别为 0.039-10μg/ml 和 0.019-10μg/ml 时，该方法呈线性。PTX 和 BAC 的定量下限分别为 0.042μg/ml 和 0.361μg/ml。根据人用药物注册技术要求国际协调会的指导原则，该方法可用于同时测定 PTX 和 BAC，具有制剂开发和生物分析研究的应用价值。
