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首页> 外文期刊>African Journal of Biotechnology >Antioxidant assessment on promethazinr HCl decomposition using RP-HPLC assay method
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Antioxidant assessment on promethazinr HCl decomposition using RP-HPLC assay method

机译：RP-HPLC法测定盐酸异丙嗪分解的抗氧化剂

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The objective of this study was to investigate the effect of different sodium metabisulfite (SMBS) concentrations under a variety of ICH recommended test conditions. An attempt was made to test the feasibility of increasing shelf life when stored under different conditions. The promethazine hydrochloride (HCL) sample solutions used according to USP 24 and BP 1999 were prepared using different concentration of sodium metabisulfite as antioxidant. Standard solution was prepared using reference promethazine and analyses were done by employing reversed-phase high-performance liquid chromatography (RP-HPLC). The method used is efficient in acceptable resolution. The effect of different concentrations of SMBS on promethazine was investigated in promethazine HCL degradation. Chemical and physical stability was conducted in different conditions. The result shows that the drug was liable to degradation in basic pH medium condition, though the extent of degradation varied. Separation of the drug and the degradation products under various conditions was successfully achieved. The method was validated and the response was linear (r=0.9998) in the drug concentration range of 5 to 50 μg. The mean values (±RSD) of slope and intercept were 46376 (±0.006975) and 200049 (±0.4009), respectively. The recovery of the drug ranged between 98.3 and 101.16% from the mixture of degradation products. SMBS concentration influences the degradation process. Increase in concentration resulted in decrease of promethazine degradation. The developed method is simple and accurate in use for analysis of the drug and its degradation products. Antioxidant (SMBS) has important role in preventing promethazine degradation beside other factors.
机译：这项研究的目的是研究在各种ICH建议的测试条件下不同浓度的焦亚硫酸钠（SMBS）的影响。试图测试在不同条件下储存时延长保质期的可行性。使用不同浓度的焦亚硫酸钠作为抗氧化剂，制备了根据USP 24和BP 1999使用的盐酸异丙嗪（HCL）样品溶液。使用参考异丙嗪制备标准溶液，并通过反相高效液相色谱（RP-HPLC）进行分析。所使用的方法在可接受的分辨率上有效。在异丙嗪盐酸盐降解中研究了不同浓度的SMBS对异丙嗪的影响。在不同条件下进行化学和物理稳定性。结果表明，尽管降解程度不同，但该药物在碱性pH介质条件下仍易于降解。成功实现了在各种条件下药物和降解产物的分离。该方法经过验证，在5至50μg的药物浓度范围内响应呈线性（r = 0.9998）。斜率和截距的平均值（±RSD）分别为46376（±0.006975）和200049（±0.4009）。从降解产物的混合物中，药物的回收率在98.3％至101.16％之间。 SMBS浓度会影响降解过程。浓度增加导致异丙嗪降解降低。所开发的方法用于分析药物及其降解产物简单，准确。除其他因素外，抗氧化剂（SMBS）在防止异丙嗪降解方面也具有重要作用。

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