Development and Validation of HPLC Method for the estimation of Triamcinolone Acetonide and 5-Fluorouracil

YMER Digital Pub Date : 2022-08-19 DOI:10.37896/ymer21.08/63
Gulati Diksha
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Abstract

A sensitive HPLC method has been developed and validated for the determination of Triamcinolone Acetonide and 5-Fluorouracil in topical formulations. The developed method is found to be specific, reproducible and stability indicating. The Phenomenex C18, 250 × 4.6 mm, 5µm particle size column was used and mobile phase contains two solvents: Solvent A contains 10mM phosphate buffer pH 3.0 and solvent B was Acetonitrile. The detector linearity was established from concentrations ranging from 1 μg/ml to 10 μg/ml for both Triamcinolone Acetonide and 5-Fluorouracil with a correlation coefficient of 0.999. The limit of detection(LOD) and limit of quantification(LOQ) for Triamcinolone Acetonide was found to be 0.04 and 0.13 respectively and 5-Fluorouracil was found to be 0.01 and 0.03 respectively. The method was proved to be robust with respect to changes in flow rate, column temperature, mobile phase ratio and detector wavelength. Keywords: Triamcinolone Acetonide, 5-fluorouracil, Validation, HPLC method, topical formulations
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高效液相色谱法测定曲安奈德和5-氟尿嘧啶含量的建立与验证
建立了一种高效液相色谱法测定外用制剂中曲安奈德和5-氟尿嘧啶的含量。该方法专属性强,重复性好,稳定性好。采用Phenomenex C18, 250 × 4.6 mm, 5µm粒径柱,流动相为两种溶剂:溶剂A为10mM pH为3.0的磷酸盐缓冲液,溶剂B为乙腈。曲安奈德和5-氟尿嘧啶的检测浓度在1 ~ 10 μg/ml范围内呈线性,相关系数为0.999。曲安奈德的检测限(LOD)和定量限(LOQ)分别为0.04和0.13,5-氟尿嘧啶的检测限和定量限分别为0.01和0.03。结果表明,该方法对流量、柱温、流动相比和检测器波长的变化具有较好的鲁棒性。关键词:曲安奈德,5-氟尿嘧啶,验证,高效液相色谱法,外用制剂
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