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高效液相色谱法和薄层色谱法测定药物制剂及血清中的桂利嗪。

LC and TLC determination of cinnarizine in pharmaceutical preparations and serum.

作者信息

Hassan Saad S M, Elmosallamy Mohamed A F, Abbas Alaa B

机构信息

Department of Chemistry, Faculty of Science, Ain Shams University, Cairo, Egypt.

出版信息

J Pharm Biomed Anal. 2002 May 15;28(3-4):711-9. doi: 10.1016/s0731-7085(01)00662-8.

Abstract

New high performance liquid chromatography (HPLC) and thin layer densitometry (TLC) methods are developed for quantification of cinnarizine in dosage forms in the presence of its photo-degradation products and related substances and in the presence of its metabolites in serum. Mobile phases consisting of benzene-methanol-formic acid (80:17:3) and methanol-acetate buffer of pH 4 (70:30) are satisfactorily used for resolution of cinnarizine from associated substances by TLC and HPLC techniques, respectively. The lower detection limits are 16 and 10 ng microl(-1) of cinnarizine with standard deviations of 1.3 and 1.1% with TLC and HPLC, respectively. The methods are used for assessment of drug purity, stability, bioavailability, bioequivalency and tablet dissolution rate. Four cinnarizine related substances and six drug degradation products are isolated and identified by infrared and mass spectrometry. The results obtained by both techniques are in good agreement and offer the advantages of reproducibility and accuracy.

摘要

开发了新的高效液相色谱(HPLC)和薄层光密度法(TLC),用于在存在西那嗪光降解产物、相关物质以及血清中其代谢物的情况下,对剂型中的西那嗪进行定量分析。分别由苯 - 甲醇 - 甲酸(80:17:3)和pH 4的甲醇 - 醋酸盐缓冲液(70:30)组成的流动相,通过TLC和HPLC技术分别能令人满意地将西那嗪与相关物质分离。TLC和HPLC对西那嗪的最低检测限分别为16和10 ng μL⁻¹,标准偏差分别为1.3%和1.1%。这些方法用于评估药物纯度、稳定性、生物利用度、生物等效性和片剂溶出速率。通过红外光谱和质谱分离并鉴定了四种西那嗪相关物质和六种药物降解产物。两种技术获得的结果吻合良好,具有重现性和准确性的优点。

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