RP-HPLC Method Development and Validation for the Estimation of Lafutidine using Bulk and Pharmaceutical Dosage Forms

S. Janet Beula, T. Ramamohan Reddy, R. Suthakaran, M. Viswaja
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Abstract

A simple and selective LC method is described for the determination of Lafutidine in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Phosphate buffer (KH2PO4) pH4.0: Acetonitrile (30:70v/v/v), with detection of 299nm. Linearity was observed in the range 60-140µg/ml for Lafutidine (r2 =0.999) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. From the above experimental results and parameters it was concluded that, this newly developed method for the simultaneous estimation of Lafutidine was found to be simple, precise, accurate and high resolution and shorter retention time makes this method more acceptable and cost effective and it can be effectively applied for routine analysis in research institutions, quality control department in meant in industries, approved testing laboratories, bio-pharmaceutical and bio-equivalence studies.
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原料药和药物剂型拉富丁的反相高效液相色谱测定方法的建立与验证
建立了一种简便、选择性的液相色谱法测定片剂中拉福丁的含量。色谱柱为c18,流动相为磷酸缓冲液(KH2PO4) pH4.0:乙腈(30:70v/v/v),检测波长为299nm。拉法替丁在60 ~ 140µg/ml范围内呈线性关系(r2 =0.999),所建立的方法所估计的药量与标签上的说明吻合良好。以上实验结果和参数表明,该方法简便、精确、准确、分辨率高,保留时间短,具有较高的可接受性和成本效益,可有效应用于科研机构、工业企业品管部门、认可检测实验室、生物制药和生物等效性研究的常规分析。
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