Method development and method validation of guaifenesin and dextromethorphan by RP-HPLC

P. Salomi, D. Nayak, T. Vimalakannan, K. Reddy
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Abstract

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Guaifenesin and Dextromethorphan was successfully achieve THERMO, C18, 250X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1M KH2PO4: Methanol (60:40) at a flow rate of 1.0ml/min and eluate was monitored at 280nm, with a retention time of 3.259 and 4.164 minutes for Guaifenesin and Dextromethorphan respectively. The method was validated and there response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Guaifenesin and 50µg/ml to150 µg/ml for Dextromethorphan. The values of the correlation coefficient were found to 0.999 for Guaifenesin and 1for Dextromethorphan. respectively. The LOD and LOQ for Guaifenesin were found to be 0.597 and 1.991 respectively. The LOD and LOQ for Dextromethorphan were found to be 0.1072 and 0.3572 respectively. This method was found to be good percentage recovery for were found to be 99 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.
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用反相高效液相色谱法建立愈创甘油醚和右美沙芬的方法及方法验证
一种简便、精确、准确、重现性好的反相高效液相色谱同时测定原料药和制剂含量的新方法。采用0.1M KH2PO4:甲醇(60:40),流速为1.0ml/min, THERMO, C18, 250X4.6mm, 5µm或等量分离,洗脱液在280nm处监测,愈创木酚和右美沙芬的保留时间分别为3.259和4.164分钟。结果表明:愈创甘油醚在50µg/ml ~ 150µg/ml范围内、右美沙芬在50µg/ml ~ 150µg/ml范围内呈线性关系;愈创甘油醚和右美沙芬的相关系数分别为0.999和1。分别。愈创木酚素的LOD和LOQ分别为0.597和1.991。右美沙芬的定量限和定量限分别为0.1072和0.3572。该方法的回收率分别为99和100,表明该方法具有较高的准确度。该方法的特异性表明,标准品的保留时间与样品的保留时间具有良好的相关性,因此,该方法可以在不受片剂剂型辅料干扰的情况下,对样品中的分析物进行特异性测定。根据ICH指南对该方法进行了线性、准确度、精密度、特异性和鲁棒性的广泛验证。
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