Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, 226031, India.
Academy of Scientific & Innovative Research (AcSIR), Ghaziabad, 201002, India.
Bioanalysis. 2023 Jun;15(11):601-620. doi: 10.4155/bio-2023-0046. Epub 2023 May 31.
A reliable, sensitive, HPLC method was developed and validated to simultaneously quantify raloxifene (RLX) and cladrin (CLD). The C18 column was used to analyze RLX and CLD at λ 285 and 249 nm. The mobile phase was composed of acetonitrile and 35:65% v/v aqueous solution of 0.1% formic acid. The method was linear over the linearity range of 0.078-20 μg/ml, and the limit of detection and limit of quantification for RLX and CLD were 0.191 and 0.228 and 0.581 and 0.69 μg/ml, respectively. In accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, the developed method is precise and accurate for simultaneous estimation of RLX and CLD with applications in liver microsomal stability in mice, rabbits, dogs, monkeys and humans.
建立并验证了一种可靠、灵敏的 HPLC 法，可同时定量分析雷洛昔芬（RLX）和克拉屈滨（CLD）。采用 C18 柱，于 λ 285nm 和 249nm 处分别对 RLX 和 CLD 进行分析。流动相由乙腈和 35:65%v/v 的 0.1%甲酸水溶液组成。该方法在 0.078-20μg/ml 的线性范围内呈线性，RLX 和 CLD 的检测限和定量限分别为 0.191 和 0.228μg/ml 以及 0.581 和 0.69μg/ml。根据人用药物注册技术要求国际协调会的指导原则，该方法精密度和准确度良好，可用于同时评估 RLX 和 CLD，已应用于小鼠、兔、犬、猴和人体内肝微粒体稳定性的研究。
