替扎尼定和布洛芬原料药和剂型的HPLC测定方法的建立与验证

Md. Abdul Sattar, M. S. Sree Lakshmi, D. S. Jyothi, M. Sudha, M. K. Siva Krishna
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引用次数: 0

摘要

建立了反相高效液相色谱法测定替扎尼定和布洛芬含量的新方法。采用Intersil ODS C18色谱柱(250×4.6mm) 5.0µm,流速1.0ml/min,流动相比(40:60 v/v)磷酸氢钾缓冲液:乙腈pH 3.2(以正磷酸调节pH),检测波长269nm,建立了替扎尼定和布洛芬的分离色谱条件。采用岛津高效液相色谱法,紫外检测器2450,Spinchrom -软件版本2。替扎尼定的浓度范围为0.6 ~ 1.4µg/ml,布洛芬的浓度范围为120 ~ 280µg/ml。替扎尼定和布洛芬的回收率在98.0% ~ 102.0%之间。由于不存在流动相的干扰,该方法具有特异性。通过分别改变流量和波长变化以及由不同的分析人员进行分析,可以看出该方法具有较强的鲁棒性。
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Development and Validation of a HPLC Method for the Estimation of Tizanidine and Ibuprofen in Bulk and Dosage forms
A new method was established for estimation of Tizanidine and Ibuprofen by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tizanidine and Ibuprofen by using Intersil ODS C18 column (250×4.6mm) 5.0µm, flow rate was 1.0ml/min, mobile phase ratio was (40:60 v/v) Potassium di hydrogen Phosphate Buffer: Acetonitrile pH 3.2 (pH was adjusted with Ortho-phosphoric acid), detection wavelength was 269nm. The instrument used was Shimadzu HPLC, UV detector 2450, Spinchrom -software version-2. The method shows linearity between the concentration range of 0.6-1.4µg/ml for Tizanidine and 120-280 for Ibuprofen. The % recovery of Tizanidine and Ibuprofen were found to be in the range of 98.0% - 102.0%. As there was no interference due to mobile phase, the method was found to be specific. The method was robust as observed from insignificant variation in the results of analysis by changes in Flow rate and wavelength variation separately and analysis being performed by different analysts.
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