Micellar liquid chromatographic determination of salbutamol sulfate in presence of methyl paraben, propyl paraben and benzoic acid: application to content uniformity testing

Abstract

A micellar liquid chromatographic method was developed for the determination of salbutamol sulfate in presence of methyl paraben, propyl paraben and benzoic acid (syrup additives) using C8 column and mobile phase consisting of water (containing 0.1 % sodium dodecyl sulfate, 0.1 % glacial acetic acid and 0.1 % triethylamine, pH = 3.45):acetonitrile (55:45, v/v) with PDA detection at 220 nm at a flow rate 1 mL/min. Under these conditions, separation of the four components was achieved in less than 9 min. Analytical characteristics such as limit of detection, limit of quantitation, linearity range, accuracy, precision and the influence of the various method parameters (robustness study) were evaluated. The method was validated over the concentration range 1–50 μg/mL of salbutamol sulfate. Statistical analysis between the suggested method and the official HPLC method using Student’s t and F-ratio tests reveals that the suggested method is as accurate and precise as the official one.