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Study On The Application Of HPLC In Pharmaceutical Quality Control Of Tamsulosin Hydrochloride, Yankening Tablets And Yujin Yinxie Tablets

Posted on:2010-03-18Degree:MasterType:Thesis
Country:ChinaCandidate:Y H WangFull Text:PDF
GTID:2121360272994191Subject:Analytical Chemistry
Abstract/Summary:PDF Full Text Request
There are four parts in this thesis. The development and applications of High Performance Liquid Chromatography (HPLC) in pharmaceutical analysis are reviewed in recent years. The determination methods of Tamsulosin Hydrochloride and its related substances, four active components in Yankening Tablets and curcumin in Yujin Yinxie Tablets are established by HPLC, which provide good measures for the quality control of drugs.In the first chapter, the development and applications of High Performance Liquid Chromatography in pharmaceutical analysis are reviewed.In the second chapter, a method was established for the determination of content of Tamsulosin hydrochloride sustained release capsules and related substances by HPLC.The analysis was carried out with ODS (150 mm×4.6 mm,5μm)Column, using methanol-0.2 mmol·L-1 Na2HPO4-KH2PO4 (pH 5.9) (6:4) as the mobile phase. The flow rate was 1.0 mL·min-1,the detection was set at 275 nm and the column temperature was maintained at 30℃.The average recoveries of tamsulosin hydrochloride, (R)-5-(2-aminopropyl)-2-methoxybenzenesulfonamide and 2-(2-ethoxyphenoxy) ethyl bromide were 100.8%, 105.1% andl03.5%, respectively. The proposed method has good selectivity and sensitivity. It was not only an effective, reliable detection means for monitoring the quality of Tamsulosin sustained-release capsules, but also a reference for monitoring the quality of the product in the process of synthesis.In the third chapter, a method was established for the determination of four active components in Yankening Tablets by HPLC.Yankening tablets contain five medicinal herbs: Rhizoma coptidis, cortex phellodendri, drug-radix isatidis, rhubarb and radix scutellariae. Berberine hydrochloride, baicalin,emodin and chrysophanol are the main active components, which play great role for the effectiveness of the preparation.The proposed RP-HPLC method was established for the simultaneous determination of berberine hydrochloride, baicalin, emodin and chrysophanol in Yankening Tablets, which is suitable for the quality control of Yankening tablets. The average recoveries of them were 98.5%,104.2%,99.1%,107.1%, respectively. In the forth chapter, a method was established for the determination of curcumin in Yujin Yinxie tablets by HPLC.Yujin Yinxie tablets are the compound preparation composed by nineteen medicinal herbs such as radix curcumae, rhizome zedoariae, safflower, angelica, Gentiana macrophylla, realgar, et al..Curcumin is one of the main active components contained in the rhizome of radix curcumae and zedoariae. It has been reported to possess a variety of pharmacological activities such as anti-inflammatory, anti-lipase effects, antioxidant, anti-tumor promoting. The proposed RP-HPLC method was established for the determination of curcumin in Yujin Yinxie tablets. The average recovery and RSD of curcumin were 98.67 % and 2.95%, respectively. It was proved to be specific, accurate and convenient, which was suitable for the quality control of Yujin Yinxie tablets.
Keywords/Search Tags:High Performance Liquid Chromatography, Pharmaceutical Analytsis, Tamsulosin Hydrochloride, Yankening tablets, Yujin Yinxie tablets
PDF Full Text Request
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