应用稳定性指示 RP-HPLC 方法定量口服分散片剂型中的替卡格雷

Cheepurupalli Prasad, Vdl Abhisri, Shanthi Kalla, Padma Kalavala, Kamuju Kandala, Satya Priyanka, Abhiram Kamuju, Kandula Vijay, Juttaka Prasad, Cheepurupalli
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引用次数: 0

摘要

本研究建立并验证了一种简单、快速、准确和精确的指示稳定性高效液相色谱法,用于测定口服分散片中的Ticagrelore。药物的分离采用岛津高效液相色谱仪,该仪器由 LC- 20 AD 二元梯度泵、可变波长可编程 SPD-20A 检测器和 SCL 系统控制器组成。固定相为 C18G 色谱柱(250 毫米 x 4.6 毫米,5 微米),流动相为甲醇和水,比例为 25:75 v/v。该方法在 10-90 μg/ml 浓度范围内线性反应良好,相关系数为 0.999。流速保持为 1.0 ml/min,流出液在 254 nm 波长下监测。保留时间为 5.786 分钟。对该方法的准确度、精密度、线性、坚固性、稳健性、溶液稳定性、选择性和强制降解研究进行了统计验证。施加的胁迫条件包括酸、碱水解、水胁迫、氧化、光解和热。降解产物不干扰替卡格雷的检测,因此该方法可视为一种稳定性指示方法。研究结果符合 ICH 指南的要求,因此该方法可用于口服分散片中替卡格雷的测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of Stability-indicating RP-HPLC Method for quantification of Ticagrelor In Oral dispersible tablet dosage form
A simple, rapid, accurate and precise stability-indicating HPLC method was developed and validated for the determination of Ticagrelore in oral dispersable tablets. Separation of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of methanol and water in the ratio of 25: 75 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.999. The flow rate was maintained at 1.0 ml/min and effluents were monitored at 254 nm. The retention time was 5.786 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and forced degradation studies. Stress conditions including acid, alkali hydrolysis, water stress, oxidation, photolysis, and heat were applied. The degradation products did not interfere with the detection of Ticagrelor, thus the method can be considered as a stability indicating method. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of Ticagrelore in oral dispersible tablets.
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