Development spectrophotometric method of determination mebhydrolin in dosage forms

Abstract

Allergic diseases have a clear tendency to increase worldwide. Mebhydrolin napadizilat is one of the most famous antihistamines H1-receptor blockers. Mebhydrolin high therapeutic activity, as well as low price leads to its popularity. Drugs based on it are produced by leading pharmaceutical companies in Ukraine. The development of simple and precise methods for quantitative determination of mebhydrolin in dosage forms is an actual problem of modern pharmaceutical analysis. Aim : The development of high sensitive, convenient and cheap methods for spectrophotometric quantitative determination of mebhydrolin in pharmaceutical phormulations. The methods validation according to the requirements of the State Pharmacopoeia of Ukraine. Methods : Absorption of the reaction products of mebhidrolin and bromtymol blue was measured in the wavelength range of 350-700 nm using spectrophotometer Specord 200. Results : A new spectrophotometric method for quantitative determination of mebhydrolin was developed. The method is based on mebhydrolin interaction with bromothymol blue in chloroform with ion-pair complex formation (maximum absorption at 412 nm). The new technique is applied to dosage forms - tablets, dragees and pellets produced by Ukrainian pharmaceutical companies. Main characteristics of validation requirements of the State Pharmacopoeia of Ukraine were determined. It is proved that the method can be correctly reproduced and is suitable for use in pharmaceutical and other chemical analytical laboratories