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A Novel Ultra Performance Liquid Chromatography-PDA Method Development and Validation for Alectinib in Bulk and its Application to Tablet Dosage Form

机译:一种新型超优性液相色谱-PDA方法的焊接吲哚溶液及其应用于平板电脑剂型的应用

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Objectives: To develop a novel ultra-performance liquid chromatographic technique for the estimation of alectinib in a API and tablet. Methods: The chromatographic separation was achieved using DIKMA Endoversil (2.1 x 50mm, 1.7μm) column, mobile phase was phosphate buffer, pH 4.6 and methanol as a mobile phase (45:55) with a flow rate of 0.4 mL/min and eluent was monitored at 265 nm. The method was continued and validated in accordance with International conference on harmonization guidelines. Validation study revealed the specificity and reliability of the method. Results: In this method alectinib was eluted with retention time of 0.418 min. Calibration curve plots were found linear over the concentration ranges 1-100 μg/mL for alectinib. Limit of detection was 0.015μg/ml and limit of quantification was found 0.07μg/mL. The % assay of the marketed dosage form was found 97.80 %, even the present approach was found to be effective in the analysis of alectinib in force degradation condition. Conclusion: The experiential evidences of all the study results revealed the suitability of the estimation of alectinib in API and tablet formulation.
机译:目的:开发一种新型超高性能液相色谱技术,用于估计API和片剂中的壁鞘。方法:使用Dikma Endoveril(2.1×50mm,1.7μm)柱实现色谱分离,流动相是磷酸盐缓冲液,pH4.6和甲醇作为流动相(45:55),流速为0.4ml / min和洗脱液被监测为265纳米。根据协调指南国际会议继续和验证该方法。验证研究揭示了该方法的特殊性和可靠性。结果:在该方法中,通过保留时间为0.418分钟洗脱莱切替尼。发现校准曲线图在浓度范围内线性,用于壁鞘1-100μg/ ml。检测限为0.015μg/ ml,并发现定量限制为0.07μg/ ml。发现营销剂型的%测定结果为97.80%,即使发现本方法也有效地在邻接肺化中的降解条件的分析中有效。结论:所有研究结果的体验证据揭示了API和片剂配方中邻接in的适用性。

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