Abstract

RP-HPLC-DAD METHOD FOR THE SIMULTANEOUS QUANTIFICATION OF INDACATEROL AND GLYCOPYRRONIUM IN THEIR PHARMACEUTICAL FORMULATION

Nasr Mohamed A. El-Abasawy, Khalid Abdel-Salam M. Attia, Ahmed A. Abouserie, Ahmed El-Olemy and Ayman Osman Elsayed*

ABSTRACT

A simple, sensitive and accurate reversed phase HPLC method was developed and validated for the simultaneous determination of indacaterol maleate and glycopyrronium bromide in commercial powder for inhalation capsules. The method has shown adequate separation of indacaterol maleate and glycopyrronium bromide. Separation was achieved on supelco C18 column (25 cm X 4.6mm, 5μm particle size) using mobile phase consists of acetonitrile: methanol: water (50:30:20, by volume). The retention times for glycopyrronium bromide and indacaterol maleate were 4.051 and 5.310 minutes respectively. Linearity of the proposed method was investigated in the range of 1-12 μg/ml (r2 =0.9998) for indacaterol maleate and 0.5-6 μg/ml (r2 =0.9998) for glycopyrronium bromide. The limit of detection (LOD) was 0.1749 μg/ml for indacaterol maleate and 0.0341μg/ml for glycopyrronium bromide. The limit of quantification (LOQ) was 0.5301 μg/ml for indacaterol maleate and 0.1034 μg/ml for glycopyrronium bromide. The proposed method was validated according to International Conference on Harmonization (ICH) guidelines, statistically compared with a reported spectrophotometric method and successfully applied for the simultaneous determination of both drugs in their combined dosage form.

Keywords: Indacaterol maleate, Glycopyrronium bromide, RP-HPLC-DAD.