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| 目的：克霉唑阴道泡腾片为已有国家标准的药品，按照已有国家标准进行含量测定，以无水乙醇为溶剂，采用分光光度法测定误差接近8%，为此更换溶剂，建立新的分析方法，以达到质量可控的目的。方法：根据克霉唑阴道泡腾片中主药和辅料的理化性质，分析使用无水乙醇产生误差的原因，筛选新的溶剂，最终选择1、2-二氯乙烷为溶剂，采用分光光度法，在261nm的波长处测定吸收度，以对照品法计算本品含量，并对此方法进行验证（包括专属性、灵敏度、被测溶液的稳定性、线性范围、系统精密度、方法精密度、回收率试验）。结果：线性范围50～400μg/ml，平均回收率为100.5%，RSD=0.9%。结论：本方法简便、准确、实用，可作为克霉唑阴道泡腾片含量测定的方法。 |
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x1360(金币+30,VIP+0):辛苦了，谢谢 5-16 18:54
x1360(金币+30,VIP+0):辛苦了，谢谢 5-16 18:54
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Objective: Clotrimazole vaginal tablet is a drug with national standards. To achieve the purpose of quality control, it is measured in accordance with existing national standards, uses the absolute ethyl alcohol as the solvent and the errors close to 8 percent according to the spectrophotometric method. Method: Based on the physical and chemical properties of main ingredients and accessories in clotrimazole vaginal tablets, we analyzed the reason for the errors with the use of ethyl alcohol, selected new solvents and finally choose 1, 2-dichloroethane as the solvent. Then we used spectrophotometric method to measure absorbance at the wavelength of 261nm to calculate the content of it compared to grading method, and validated this method, including specificity, sensitivity, stability of the measured solvent, the linear range, systematical precision, methodological precision and recovery test. Results: The linear range is 50 ~ 400μg/ml, average recovery rate is 100.5%, RSD = 0.9%. Conclusion: This method is simple, accurate and practical. It can be used as a method for measuring content of clotrimazole vaginal tablets. [ Last edited by ustcrat on 2009-5-10 at 02:52 ] |
2楼2009-05-09 23:35:10
3楼2009-05-10 08:44:58
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hongweiwei000(金币-1,VIP+0):小木虫不支持“google translate”，这次就算了，下次再这样一定严惩，请理解和支持我们的工作，谢谢 5-14 01:06
29056917(金币+0,VIP+0):不支持机器翻译 5-16 20:19
hongweiwei000(金币-1,VIP+0):小木虫不支持“google translate”，这次就算了，下次再这样一定严惩，请理解和支持我们的工作，谢谢 5-14 01:06
29056917(金币+0,VIP+0):不支持机器翻译 5-16 20:19
| Objective: Clotrimazole vaginal tablets have national standards for drugs, there are national standards in accordance with the determination to ethanol as the solvent, the use of spectrophotometric determination of error of nearly 8 percent, for the replacement of solvent, the establishment of a new analytical methods in order to achieve the purpose of quality control. Method: In accordance with clotrimazole vaginal tablets in the main drugs and the physical and chemical properties of materials, analysis of the use of ethanol causes of errors, selection of new solvents, the final choice of 1,2 - dichloroethane as the solvent, the use of spectrophotometry law, in the determination of wavelength of 261nm absorbance, calculated by reference substance content of the goods, and validation of this method (including specific, sensitivity, measured the stability of the solution, the linear range, the system precision, method precision , the recovery test). Results: The linear range of 50 ~ 400μg/ml, average recovery was 100.5%, RSD = 0.9%. Conclusion: The method is simple, accurate, practical and can be used as clotrimazole vaginal effervescent tablets assay method. |
4楼2009-05-13 21:35:36
5楼2009-05-14 01:01:59
6楼2009-05-14 01:12:47
7楼2009-05-14 01:18:22