反相高效液相色谱法定量评价罗红霉素和氨溴索的散装和片剂剂型

K. Umadevi, Mohibul Hoque, R. Sri. S
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引用次数: 0

摘要

建立了一种快速、精确的反相高效液相色谱法,对罗红霉素和氨溴索的纯剂型和片剂进行了验证。色谱柱为Altima C18 (4.6 × 150mm, 5µm),流动相为ACN、甲醇和磷酸盐缓冲液pH4.6 (10:25:65 v/v),流速为1.0ml/min,检测波长为215nm。罗红霉素和氨溴索的保留时间分别为2.344、3.286±0.02min。该方法在罗红霉素10 ~ 50mg/ml、氨溴索2.5 ~ 12.5mg/ml浓度范围内呈线性响应。方法精密度< 2.0% RSD。该方法可用于原料药和制剂的质量控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quantitative Estimation of Roxithromycin and Ambroxol in Bulk and Tablet Dosage Forms by RP-HPLC Method
A Rapid and Precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Roxithromycin and Ambroxol, in its pure form as well as in tablet dosage form. Chromatography was carried out on Altima C18 (4.6 x 150mm, 5µm) column using a mixture of ACN, Methanol and Phosphate buffer pH4.6 (10:25:65 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 215nm. The retention time of the Roxithromycin and Ambroxol was 2.344, 3.286±0.02min respectively. The method produce linear responses in the concentration range of 10-50mg/ml of Roxithromycin and 2.5-12.5mg/ml of Ambroxol. The method precision for the determination of assay was below 2.0 %RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
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