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采用三阶导数分光光度法和高效液相色谱法同时测定药物制剂中的西替利嗪、苯丙醇胺和尼美舒利。

Simultaneous determination of cetirizine, phenyl propanolamine and nimesulide using third derivative spectrophotometry and high performance liquid chromatography in pharmaceutical preparations.

作者信息

Aly Fatma Ahmed, El-Enany Nahed, Elmansi Heba, Nabil Amany

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura, 35516, Egypt.

出版信息

Chem Cent J. 2017 Oct 5;11(1):99. doi: 10.1186/s13065-017-0326-9.

Abstract

BACKGROUND

The combination between cetirizine (CET), phenylpropanolamine (PPA) and nimesulide (NMS) under trade name Nemeriv Cp tablet is prescribed for nasal congestion, cold, sneezing, and allergy. Among all published methods for the three drugs; there is no reported method concerning estimation of CTZ, PPA and NMS simultaneously and this motivates us to develop new and simple methods for their assay in pure form and tablet preparations.

RESULTS

Two new methodologies were described for the simultaneous quantification of cetirizine (CTZ), PPA and NMS. Spectrophotometric procedures relies on measuring the amplitudes of the third derivative curves at 238 nm for CTZ, 218 nm for PPA and 305 nm for NMS. The calibration graphs were rectilinear over the ranges of 8-90 µg/mL for CTZ, 20-100 µg/mL for PPA and 20-200 µg/mL for NMS respectively. Regarding the HPLC method; monolithic column (100 mm × 4.6 mm i.d) was used for the separation. The used mobile phase composed of 0.1 M phosphate buffer and methanol in the ratio of 40:60, v/v at pH 7.0. The analysis was performed using UV detector at 215 nm. Calibration curves showed the linearity over concentration ranges of 5-40, 10-100 and 10-120 µg/mL for CTZ, PPA and NMS.

CONCLUSION

Application of the proposed methods to the laboratory prepared tablets was carried out successfully. The results were compared with those obtained from previously published methods and they were satisfactory. Graphical abstract Graphical abstract represents the chemical structures, representative chromatogram for the HPLC separation of a PPA, b NMS and c CTZ and third derivative absorption spectra of a PPA, b NMS and c CTZ for the spectrophotometric method.

摘要

背景

以商品名Nemeriv Cp片剂形式存在的西替利嗪(CET)、苯丙醇胺(PPA)和尼美舒利(NMS)的组合被用于治疗鼻塞、感冒、打喷嚏和过敏。在所有已发表的针对这三种药物的方法中,没有关于同时测定西替利嗪、PPA和NMS的报道方法,这促使我们开发新的、简单的方法来测定它们的纯品和片剂制剂。

结果

描述了两种同时定量西替利嗪(CTZ)、PPA和NMS的新方法。分光光度法是通过测量CTZ在238nm、PPA在218nm和NMS在305nm处的三阶导数曲线的振幅。校准曲线在CTZ为8 - 90μg/mL、PPA为20 - 100μg/mL、NMS为20 - 200μg/mL范围内呈线性。关于高效液相色谱法;使用整体柱(100mm×4.6mm内径)进行分离。所用流动相由0.1M磷酸盐缓冲液和甲醇按40:60(v/v)的比例组成,pH值为7.0。使用紫外检测器在215nm处进行分析。校准曲线在CTZ为5 - 40μg/mL、PPA为10 - 100μg/mL、NMS为10 - 120μg/mL浓度范围内呈线性。

结论

所提出的方法成功应用于实验室制备的片剂。将结果与先前发表的方法所获得的结果进行比较,结果令人满意。图形摘要 图形摘要展示了化学结构、高效液相色谱法分离PPA(a)、NMS(b)和CTZ(c)的代表性色谱图以及分光光度法中PPA(a)、NMS(b)和CTZ(c)的三阶导数吸收光谱。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f48b/5629192/5fd6628784ca/13065_2017_326_Figa_HTML.jpg

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