Abstract

A NEW VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF GLYCOPYRROLATE AND FORMETEROL FUMARATE IN ITS BULK AND PHARMACEUTICAL DOSAGE FORMS

N. Md. Akram* and M. Umamahesh

ABSTRACT

A New method was established for simultaneous estimation of Glycopyrrolate and Formoterol fumarate by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Glycopyrrolate and Formoterol fumarate using Xterra column (4.6×150mm) 5μ, flow rate was 1ml/min, mobile phase ratio (40:60v/v) Methanol,1ml of OPA in 1000ml waterpH 3 (pH adjusted with triethylamine), detection wavelength used by WATERS HPLC Auto Sampler, Separation module 2695, UV detector 2489, Empower-software version-2. The retention times were found to be 3.0 mins and 4.20mins. The % purity of Glycopyrrolate and Formoterol fumarate were found to be 99.80 and 99.70 respectively. The present analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Glycopyrrolate and Formoterol fumarate was found in the concentration range 9μg/ml-45μg/mland 4.8μg/ml-24μg/ml and correlation coefficient (R2) be 0.999 and 0.999, % recovery was found to be 100.01 and 100.34, % RSD for repeatability 0.3 and 0.6, % RSD for intermediate precision was 0.3 and 0.4respectively. The precision study was precision, robustness and repeatability. It is a convenient, simple and quick method for the determination of Glycopyrrolate and Formoterol fumarate its bulk and pharmaceutical dosage forms.

Keywords: Glycopyrrolate, Formoterol fumarate, HPLC, Methanol.