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A Validated Green HPTLC Method for Quantitative Determination of Dapoxetine Hydrochloride and Tadalafil in Bulk and Pharmaceutical Formulations.
Journal of Chromatographic Science ( IF 1.5 ) Pub Date : 2020-04-23 , DOI: 10.1093/chromsci/bmz115
Ibrahim A Naguib 1, 2 , Maimana A Magdy 2 , Basma H Anwar 2 , Nessreen S Abdelhamid 2
Affiliation  

Dapoxetine hydrochloride (DAP) and Tadalafil (TAD) were separated and determined quantitatively using a validated green high-performance thin layer chromatographic (HPTLC) method in their binary mixtures either as raw materials or in pharmaceutical formulations. The concentration ranges were 0.1-1.6 and 0.2-2.5 μg/band for dapoxetine and tadalafil, respectively, with accuracies of 98.93% ± 0.62 and 99.26% ± 1.39, respectively. Silica gel HPTLC F254 plates were used to carry out the separation. The mobile phase used was a mixture of ethanol-ethyl acetate (1:9 by volume), which is environmentally green and harmless. Densitometric scanning with UV detector was used to detect the separated peaks at 222 nm. ICH guidelines were followed to validate the suggested method, and the results prove that they can be used for regular analysis in quality control laboratories with compatible results.

中文翻译:

用于定量测定大剂量和药物制剂中盐酸达泊西汀和他达拉非的经验证的绿色HPTLC方法。

盐酸达泊西汀(DAP)和他达拉非(TAD)分离并使用经过验证的绿色高效薄层色谱(HPTLC)方法以二元混合物形式作为原料或药物制剂进行定量测定。达泊西汀和他达拉非的浓度范围分别为0.1-1.6和0.2-2.5μg/ band,准确度分别为98.93%±0.62和99.26%±1.39。使用硅胶HPTLC F254板进行分离。使用的流动相是乙醇-乙酸乙酯(体积比为1:9)的混合物,对环境无害且无害。使用紫外检测器进行光密度扫描,以检测222 nm处的分离峰。遵循ICH指南来验证建议的方法,
更新日期:2020-01-14
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