Abstract

Dropropizine is a peripheral antitussive drug that acts by inhibiting cough reflex through its action on the peripheral receptors and their afferent conductors. It is marketed in a racemic form or its pure enantiomer called levodropropizine and both are available worldwide in various drug dosage formulations such as tablets, sirup and oral solution. Due to the widespread use of antitussives in the clinic it is necessary to develop efficient analytical methodologies for quality control and also for pharmacokinetic, bioavailability and bioequivalence studies. This review presents a survey of the characteristics, properties and analytical methods used for drug determination, being carried out through scientific articles as well as in official compendia. From the analyzed studies, the majority reports the use of HPLC/UV techniques for drug determination, but also spectrophotometric UV/Vis methods as well as gas chromatography, and voltammetric, potentiometric and conductometric titration methods. In addition, the methodologies addressed the determination of dropropizine or levodropropizine in different types of matrices such as raw material, pharmaceutical formulations, plasma and urine. Despite the extensive clinical use of dropropizine, data from this review evidenced a still limited number of studies dealing with analytical methods for its determination in different matrices, which may be of concern since the applicability of these methods is important for quality assurance, efficacy and safety of the medicine.

摘要

Dropropizine是一种外周镇咳药，通过对外周受体及其传入导体的作用来抑制咳嗽反射，从而发挥作用。它以外消旋形式或其纯的对映体（称为左旋洛哌嗪）销售，并且两者在世界范围内都可以以各种药物剂型（例如片剂，糖浆和口服溶液）获得。由于镇咳药的广泛使用，有必要开发有效的分析方法进行质量控制以及药代动力学，生物利用度和生物等效性研究。这篇综述通过科学文章以及官方药典对用于药物测定的特性，性质和分析方法进行了概述。从分析的研究中，大多数人报告了使用HPLC / UV技术进行药物测定，但也使用了分光光度法UV / Vis方法以及气相色谱法以及伏安法，电位滴定法和电导滴定法。此外，这些方法还涉及了在不同类型的基质（例如原料，药物制剂，血浆和尿液）中测定dropropizine或levodropropizine的方法。尽管dropropizine在临床上得到了广泛的应用，但本次审查的数据表明，有关在不同基质中测定其含量的分析方法的研究仍然有限，这可能是值得关注的，因为这些方法的适用性对于质量保证，疗效和安全性很重要。的药。电位滴定法和电导滴定法。此外，这些方法还涉及了在不同类型的基质（例如原料，药物制剂，血浆和尿液）中测定dropropizine或levodropropizine的方法。尽管dropropizine在临床上得到了广泛的应用，但本次审查的数据表明，有关在不同基质中测定其含量的分析方法的研究仍然有限，这可能是值得关注的，因为这些方法的适用性对于质量保证，疗效和安全性很重要。的药。电位滴定法和电导滴定法。此外，这些方法还涉及了在不同类型的基质（例如原料，药物制剂，血浆和尿液）中测定dropropizine或levodropropizine的方法。尽管dropropizine在临床上得到了广泛的应用，但本次审查的数据表明，有关在不同基质中测定其含量的分析方法的研究仍然有限，这可能是值得关注的，因为这些方法的适用性对于质量保证，疗效和安全性很重要。的药。