Zeitschrift für Chromatographie und Trenntechniken
Offener Zugang

Abstrakt

Development and Validation of a Stability Indicating HPLC Method for the Estimation of Butamirate Citrate and Benzoic Acid in Pharmaceutical Products

Mohamed Haider

HPLC stability-indicating method has been developed for the simultaneous determination of Butamirate citrate and Benzoic acid in pharmaceutical dosage forms. Active compounds were separated on Zorbax SB-C8 column (250 mm × 4.6 mm, 5 μm Agilent) at an ambient temperature. Elution was performed with a mobile phase consisting of acetonitrile (solvent A) and a mixture of 10 gm of sodium lauryl sulphate and 5ml of 1 N sulphuric acid in 1000 ml distilled water (solvent B) at a ratio of 70:30 v/v and a flow-rate of 1.7 ml/min. Detection was performed with UV detector at 205 nm. Cough syrup preparation was subjected to long-term stability in order to demonstrate that storage conditions and degradants from both active compounds did not interfere with the quantification of Butamirate citrate and Benzoic acid. Typical validation characteristics such as linearity, range, precision, accuracy, and selectivity were evaluated for Butamirate citrate and Benzoic acid. Using the novel method, both Butamirate citrate and Benzoic acid were separated successfully. Validation studies demonstrated that the novel method possessed a linear UV response, good system precision and accuracy, high sensitivity and specificity for Butamirate citrate and Benzoic acid.