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片剂制剂中酒石酸唑吡坦含量测定的分光光度法。

Spectrophotometric methods for determination of zolpidem tartrate in tablet formulation.

作者信息

Chomwal Rajiv, Kumar Amit, Goyal Anju

机构信息

Department of Pharmaceutical Chemistry, Swami Keshvanand Institute of Pharmacy, Bikaner 334001, India.

出版信息

J Pharm Bioallied Sci. 2010 Oct;2(4):365-8. doi: 10.4103/0975-7406.72142.

DOI:10.4103/0975-7406.72142
PMID:21180474
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2996077/
Abstract

AIM

The study aims to develop simple, sensitive, rapid, accurate and precise spectrophotometric method for estimation of Zolpidem tartrate in tablet dosage forms.

MATERIALS AND METHODS

For method I, II, III and IV in a series of 10 ml volumetric flask, aliquots of standard drug solution (100 µg/ml) in 0.1N HCl were transferred and diluted with same so as to give several dilutions in concentration range of 5-30 µg/ml, 5-30 µg/ml, 10-50 µg/ml and 5-40 µg/ml respectively of zolpidem tartrate. To 5 ml of each dilution taken in a separating funnel, (5 ml of bromo phenol red, bromo cresol purple, bromo cresol green and bromo phenol blue for method I, II, III and IV respectively) reagent and 5 ml of chloroform was added. Reaction mixture was shaken gently for 5 min and allowed to stand so as to separate aqueous and chloroform layer. Absorbance maxima measured at 407 nm, 417 nm, 412 nm and 415 nm for method I, II, III and IV respectively.

RESULTS

The recovery studies were found close to 100 % that indicates accuracy and precision of the proposed methods. The statistical analysis was carried out and results of which were found satisfactory. Standard deviation values were found low that indicated reproducibility of the proposed methods.

CONCLUSION

Based on results the developed methods could be used for routine estimation of zolpidem tartrate from tablet formulations.

摘要

目的

本研究旨在开发一种简单、灵敏、快速、准确且精密的分光光度法,用于测定片剂剂型中酒石酸唑吡坦的含量。

材料与方法

对于方法I、II、III和IV,在一系列10毫升容量瓶中,移取0.1N盐酸中的标准药物溶液(100微克/毫升) aliquots,并以相同溶液稀释,以分别得到酒石酸唑吡坦浓度范围为5 - 30微克/毫升、5 - 30微克/毫升、10 - 50微克/毫升和5 - 40微克/毫升的几种稀释液。对于在分液漏斗中取的每种稀释液5毫升,(方法I、II、III和IV分别加入5毫升溴酚红、溴甲酚紫、溴甲酚绿和溴酚蓝)试剂和5毫升氯仿。反应混合物轻轻振荡5分钟,然后静置以分离水相和氯仿层。方法I、II、III和IV分别在407纳米、417纳米、412纳米和415纳米处测量最大吸光度。

结果

回收率研究发现接近100%,表明所提出方法的准确性和精密性。进行了统计分析,结果令人满意。发现标准偏差值较低,表明所提出方法的可重复性。

结论

基于结果,所开发的方法可用于从片剂制剂中常规测定酒石酸唑吡坦。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/9ef97c9806bd/JPBS-2-365-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/4500a638ccd7/JPBS-2-365-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/5ea82a931389/JPBS-2-365-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/a58ddabe6c5f/JPBS-2-365-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/9ef97c9806bd/JPBS-2-365-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/4500a638ccd7/JPBS-2-365-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/5ea82a931389/JPBS-2-365-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/a58ddabe6c5f/JPBS-2-365-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e662/2996077/9ef97c9806bd/JPBS-2-365-g004.jpg

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本文引用的文献

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Quantification of zolpidem in human plasma by high-performance liquid chromatography with fluorescence detection.
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Selective potentiometric determination of zolpidem hemitartrate in tablets and biological fluids by using polymeric membrane electrodes.使用聚合物膜电极选择性电位法测定片剂和生物流体中的半酒石酸唑吡坦。
J AOAC Int. 2004 Nov-Dec;87(6):1309-18.
3
Determination and in-process control of zolpidem synthesis by high-performance liquid chromatography.采用高效液相色谱法测定唑吡坦合成过程并进行过程控制。
J Pharm Biomed Anal. 2004 Nov 19;36(4):925-8. doi: 10.1016/j.jpba.2004.08.025.
4
Testing for zolpidem in oral fluid by liquid chromatography-tandem mass spectrometry.采用液相色谱-串联质谱法检测口腔液中的唑吡坦。
J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Nov 5;811(1):59-63. doi: 10.1016/j.jchromb.2004.03.074.
5
Validation of a method for the determination of zolpidem in human plasma using LC with fluorescence detection.使用液相色谱-荧光检测法测定人血浆中唑吡坦的方法验证
J Pharm Biomed Anal. 2000 Apr;22(3):495-504. doi: 10.1016/s0731-7085(99)00311-8.