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反相高效液相色谱法测定片剂剂型中甲基苯丙胺和普萘洛尔的方法开发与验证

Development and Validation of RP-HPLC Method for the Determination of Methamphetamine and Propranolol in Tablet Dosage Form.

作者信息

Shabir G A

机构信息

School of Life Sciences, Oxford Brookes University, Oxford, Headington Campus, OX3 0BP, United Kingdom.

出版信息

Indian J Pharm Sci. 2011 Jul;73(4):430-5. doi: 10.4103/0250-474X.95632.

DOI:10.4103/0250-474X.95632
PMID:22707828
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3374560/
Abstract

A new isocratic reversed-phase HPLC method with diode-array UV detection was developed and validated for the determination of methamphetamine and propranolol in tablet dosage forms. Chromatography was carried out on an XTerra RP18 (150×4.6 mm, 5 μm) column using 50 mM pyrrolidine (pH 11.5) - acetonitrile (50:50, v/v) as mobile phase at a flow rate of 1 ml/min. Spectrophotometric detection was performed at a wavelength of 214 nm. The linearity was established over the concentration range of 0.075-0.60 mg/ml for both drugs. The correlation coefficients (r(2)) were ≥0.9998 in each case. The relative standard deviation values for intermediate precision studies were <1%. Statistical analysis of the data showed that the method was precise, accurate, reproducible and selective for the analysis of methamphetamine and propranolol drugs. The method was successfully employed for the determination of propranolol and methamphetamine in commercially available tablet dosage form.

摘要

建立了一种采用二极管阵列紫外检测的新型等度反相高效液相色谱法,并对其进行了验证,用于测定片剂剂型中的甲基苯丙胺和普萘洛尔。色谱分析在XTerra RP18(150×4.6 mm,5μm)柱上进行,以50 mM吡咯烷(pH 11.5)-乙腈(50:50,v/v)作为流动相,流速为1 ml/min。在214 nm波长下进行分光光度检测。两种药物在0.075 - 0.60 mg/ml的浓度范围内均建立了线性关系。每种情况下的相关系数(r(2))均≥0.9998。中间精密度研究的相对标准偏差值<1%。数据的统计分析表明,该方法对于甲基苯丙胺和普萘洛尔药物的分析具有精确、准确、可重现和选择性。该方法成功用于测定市售片剂剂型中的普萘洛尔和甲基苯丙胺。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff22/3374560/bf96348179d1/IJPhS-73-430-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff22/3374560/ddc3b70ab0e0/IJPhS-73-430-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff22/3374560/ad47283f390b/IJPhS-73-430-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff22/3374560/bf96348179d1/IJPhS-73-430-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff22/3374560/ddc3b70ab0e0/IJPhS-73-430-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff22/3374560/ad47283f390b/IJPhS-73-430-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff22/3374560/bf96348179d1/IJPhS-73-430-g008.jpg

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本文引用的文献

1
Methamphetamine - Effects on Human Performance and Behavior.甲基苯丙胺——对人类机能和行为的影响
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Rapid screening method for determination of Ecstasy and amphetamines in urine samples using gas chromatography-chemical ionisation mass spectrometry.使用气相色谱-化学电离质谱法测定尿液样本中摇头丸和苯丙胺类药物的快速筛查方法。
J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Apr 5;769(2):243-51. doi: 10.1016/s1570-0232(01)00586-4.
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History of the methamphetamine problem.甲基苯丙胺问题的历史。
J Psychoactive Drugs. 2000 Apr-Jun;32(2):137-41. doi: 10.1080/02791072.2000.10400221.
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An improved HPLC method for analysis of methamphetamine and its metabolites in plasma.
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