Bansal Ranju, Singh Ranjit, Kaur Khushpal
University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, 160 014, India.
BMC Chem. 2021 Apr 24;15(1):27. doi: 10.1186/s13065-021-00752-3.
Environment-friendly fast and accurate mid-infrared spectroscopic methods have been developed for the quantitative analysis of doxorubicin hydrochloride (DOX) and arterolane maleate (ALM) in bulk and marketed formulations. Both transmittance and reflectance modes have been used for the analysis and a comparison has been drawn for better accuracy. The analytical methods were validated in accordance with International Council for Harmonisation (ICH) guidelines RESULTS: The proposed methods have been successfully developed and validated for the quantification of doxorubicin and arterolane maleate in solid bulk and dosage form. High recovery values in both the modes, while analysing DOX and ALM, indicated good accuracy of the methods. The methods showed excellent repeatability and intermediate precision [% RSD (Relative Standard Deviation < 2.0%]. The assay values of the drugs in solid dosage forms were also found close to the labelled claim.
The proposed Fourier transform infrared (FT-IR) spectroscopic methods were found to be specific, reproducible, valid and could be used as general methods for the quantification of most of the solid drug preparations such as tablets, capsules and powders.
已开发出环境友好型快速准确的中红外光谱方法，用于定量分析原料药及市售制剂中的盐酸多柔比星（DOX）和马来酸蒿乙醚（ALM）。分析中采用了透射和反射两种模式，并进行了比较以提高准确性。所建立的分析方法按照国际协调理事会（ICH）指南进行了验证。
所提出的方法已成功开发并验证，可用于定量分析固体原料药和剂型中的多柔比星和马来酸蒿乙醚。在分析DOX和ALM时，两种模式下均具有较高的回收率，表明该方法具有良好的准确性。这些方法显示出优异的重复性和中间精密度[相对标准偏差（%RSD）<2.0%]。还发现固体剂型中药物的含量测定值与标签标示量接近。
所提出的傅里叶变换红外（FT-IR）光谱方法具有特异性、可重复性、有效性，可作为大多数固体药物制剂（如片剂、胶囊和散剂）定量分析的通用方法。
