Development and Validation of RP-HPLC Method for SimultaneousDetermination of Diclofenac Sodium and Eperisone Hydrochloride inPharmaceutical Dosage Form

A. Divya, Y. Vishwanadham, Mounika
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Abstract

The RP-HPLC (Reversed-Phase High-Performance Liquid Chromatography) method was developed for the simultaneous determination of Eperisone Hydrochloride and Diclofenac Sodium in capsule dosage form. After that optimization good chromatographic separation was achieved by Isocratic mode with a mixture of Acetonitrile: Phosphate buffer pH-5.8 in the ratio 55:45 v/v as the mobile phase and detection wavelength of 225 nm. The drud retention times for Eperisone Hydrochloride and Diclofenac Sodium found to be 3.143 min and 4.753 min respectively. The linearity, this method was found in the concentration range of 90-210 μg/ml for Eperisone Hydrochloride and 60-140 μg/ml for Diclofenac Sodium. The LOD and LOQ for Eperisone Hydrochloride were found to be 1.55 and 4.71 μg/ml respectively. The LOD and LOQ for Diclofenac Sodium were found to be 2.08 and 6.31 μg/ml respectively. This method was found to be good as the percentage recovery for Eperisone Hydrochloride and Diclofenac Sodium were found to be 100.86 and 99.81 respectively, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the drug so, the sample without interference from excipients of capsule dosage form.
反相高效液相色谱法同时测定药品剂型中双氯芬酸钠和盐酸依培立松的含量
建立了反相高效液相色谱(RP-HPLC)法同时测定胶囊剂型盐酸依培立松和双氯芬酸钠的含量。优化后,以乙腈:磷酸盐缓冲液pH-5.8,比为55:45 v/v为流动相,检测波长为225 nm,采用等压模式获得了良好的色谱分离效果。盐酸依培立松和双氯芬酸钠的留药时间分别为3.143 min和4.753 min。方法在盐酸依培立松90 ~ 210 μg/ml、双氯芬酸钠60 ~ 140 μg/ml的浓度范围内具有良好的线性关系。盐酸依培立松的定量限和定量限分别为1.55和4.71 μg/ml。双氯芬酸钠的检出限和定量限分别为2.08和6.31 μg/ml。结果表明,该方法的回收率为100.86,双氯芬酸钠的回收率为99.81,准确度较高。该方法的特异性表明,标准品的保留时间与药物的保留时间具有良好的相关性,因此样品不受辅料的干扰。
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