Naraparaju Swathi, Mukti Ambati, Anumolu Durga Panikumar, Chaganti Soujanya
Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Chemistry, Hyderabad, India.
Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis, Hyderabad, India.
Turk J Pharm Sci. 2023 Aug 22;20(4):234-239. doi: 10.4274/tjps.galenos.2022.46364.
A new, simple, and affordable spectrofluorimetric method was established for quantification of capecitabine in bulk and in marketed formulations.
Native fluorescence of capecitabine in 0.1% () cetrimide was measured at 386 nm after excitation at 313 nm.
A linear relationship between fluorescence intensity and capecitabine concentration was noticed in 0.2-1.0 μg/mL range. The method was supported by checking several validation parameters as stated using International Conference on Harmonization (ICH) guidelines. The limit of detection (LOD) and quantification (LOQ) values (0.032 and 0.096 μg/mL, respectively) and results of validation parameters demonstrated that the method procedure were sensitive, accurate, precise, and reproducible (% relative standard deviation <2.0). The percentage assay in commercial formulation was found to be 99.2, which agrees with ICH guidelines.
Due to the above findings, developed method can be successfully adopted for routine analysis of capecitabine in pharmaceutical dosage forms.
建立一种新的、简单且经济的荧光分光光度法，用于定量测定原料药及市售制剂中的卡培他滨。
在313nm激发后，于386nm处测量卡培他滨在0.1%（）十六烷基三甲基溴化铵中的固有荧光。
在0.2 - 1.0μg/mL范围内，荧光强度与卡培他滨浓度呈线性关系。按照国际协调会议（ICH）指南所述，通过检查多个验证参数来支持该方法。检测限（LOD）和定量限（LOQ）值（分别为0.032和0.096μg/mL）以及验证参数结果表明，该方法步骤灵敏、准确、精密且可重现（相对标准偏差<2.0%）。市售制剂中的含量测定百分比为99.2，符合ICH指南。
基于上述研究结果，所开发的方法可成功应用于药物剂型中卡培他滨的常规分析。
