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Development of basic tests for sildenafil citrate and sildenafil citrate tablet

机译:开发柠檬酸西地那非和柠檬酸西地那非片的基本测试

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The work involves the development of basic tests for sildenafil citrate (drug substance) and sildenafil citrate tablet (dosage form). The Basic Tests encompass physical observation, melting characteristics, colour and other test reactions for the drug substance and the dosage form. These tests are supplemented with thin layer chromatography. The test tube identification reactions were carried out to demonstrate the presence of the phenyl ether and sulphonamide functional groups as well as the N-substituted piperazine and pyrimidine rings on the molecule. The presence of sulphur and nitrogen in the drug moiety were also confirmed. The Rfvalues obtained from the chromatograms using three different solvent systems were found to be approximately same for sildenafil in the extracted form and the powdered tablet. A summary of test result for sildenafil citrate and sildenafil citrate tablet is presented that could be of use in quick verification of the identity of the drug.
机译:这项工作涉及开发枸sil酸西地那非(药物物质)和枸sil酸西地那非片剂(剂型)的基础测试。基本测试包括对原料药和剂型的物理观察,熔融特性,颜色和其他测试反应。这些测试辅以薄层色谱法。进行试管鉴定反应以证明分子上存在苯基醚和磺酰胺官能团以及N-取代的哌嗪和嘧啶环。还证实了药物部分中硫和氮的存在。发现使用三种不同溶剂系统从色谱图获得的Rf值对于西地那非的提取形式和粉状片剂大致相同。总结了枸sil酸西地那非和枸sil酸西地那非片的测试结果摘要,可用于快速验证药物的身份。

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