Development and Validation of a New Stable HPLC Method for the Assay of Butamirate Citrate in Pharmaceutical Formulations

Butamirate citrate is a non-narcotic cough suppressant. A straightforward and accurate analytical method is indispensable for the assay of butamirate citrate for the pharmaceutical industry. In the present study, a high performance liquid chromatography (HPLC) method with UV detection was developed and validated for the estimation of butamirate citrate from tablet and syrup formulations. 1:1 v/v mixture of acetonitrile and 0.008M 1-hexane sulfonic acid sodium salt was used as mobile phase and the determination was taken at 258.0 nm. Strict linearity was obtained in the range of 28 μg.mL to 2020 μg.mL for the concentration of butamirate citrate with a R value of 0.9999. The limit of detection (LOD) was observed as 23.5 μg.mL (4.70 x 10 M). The developed method efficiently separated the analyte from its degradation products derived from different stress conditions like alkali, acid, oxygen and temperature. This developed method was applied for the assay of different commercial brands of butamirate citrate (tablets and syrups) and satisfactory results were obtained. The method is selective, sensitive, accurate, precise, rugged and robust. Thus the method can be used for the routine analysis of butamirate citrate in pharmaceutical preparations.