RP-HPLC method development and validation for the estimation of antifungal drug terbinafine HCL in bulk and pharmaceutical dosage form

R. Sireesha, P Syam Vijayakar, V. P. Kumar, B. Sivagami, P. Sikdar, M. Babu
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Abstract

In the present work RP-HPLC method has been developed for the quantitative estimation of Terbinafine hydrochloride in bulk drug and pharmaceutical formulations. A rapid and sensitive RP-HPLC Method with PDA detection (220 nm) for routine analysis of in Bulk drug and Pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of Potassium dihydrogen phosphate and Acetonitrile (65:35 v/v) with flow rate 1.5 ml/min. The linearity was found to be in the range of 50-150 µg/ml with (r2=0.999). The proposed method was validated by determining sensitivity, accuracy, precision, LOD, LOQ and system suitability parameters according to ICH guidrelines.
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反相高效液相色谱法测定抗真菌药物特比萘芬HCL原料药和制剂剂型的含量及验证
建立了反相高效液相色谱法定量测定原料药和制剂中盐酸特比萘芬的含量。建立了一种快速、灵敏的PDA (220 nm)反相高效液相色谱(RP-HPLC)方法,用于原料药和制剂的常规分析。流动相为磷酸二氢钾与乙腈的混合物(65:35 v/v),流速为1.5 ml/min。在50 ~ 150µg/ml范围内呈线性关系(r2=0.999)。根据ICH指南,通过测定灵敏度、准确度、精密度、定量限、定量限和系统适用性参数,对该方法进行了验证。
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