原料药及复方片剂中氟哌啶醇和三己苯酯含量的反相高效液相色谱测定方法的建立与验证

E. Amulya, N. N. Kumar, C. Mounika, V. Kowmudi, N. Supriya, K. Madhuri
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引用次数: 1

摘要

建立了一种快速、精确的反相高效液相色谱法,对三己苯基和氟哌啶醇进行了纯度和片剂的验证。色谱柱为Altima C18 (4.6 × 150mm, 5μm),流动相为甲醇:TEA缓冲液pH为4.5:乙腈(50:25:25),流速为1.0ml/min,检测波长为225 nm。三己苯醚和氟哌啶醇的停留时间分别为2.102、3.537±0.02min。该方法在三苯乙烯浓度15 ~ 75ppm和氟哌啶醇浓度37.5 ~ 187.5ppm范围内产生线性响应。该方法精密度小于2.0%RSD。该方法可用于药物制剂的质量控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Haloperidol and Trihexyphenidyl in API and Combined Tablet Dosage Form
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Trihexyphenidyl and Haloperidol, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Altima C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 225 nm. The retention time of the Trihexyphenidyl and Haloperidol was 2.102, 3.537±0.02min respectively. The method produce linear responses in the concentration range of 15-75ppm of Trihexyphenidyland 37.5-187.5ppm of Haloperidol. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of pharmaceutical formulations.
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