Development and Validation of RP- HPLC Method for Simultaneous Determination of Ascorbic Acid and Salicylamide in their Binary Mixtures: Application to Combined Tablets

摘要

A new simple, rapid and sensitive reversed-phase liquid chromatographic method was developed and validated for the simultaneous determination of ascorbic acid (ASC) and salicylamide (SAL) in their combined dosage form. The analysis was carried out on CLC Shim-pack C8 column (250 x 4.6 mm, 5 μm particle size) using a mobile phase consisting of methanol: 0.03 M phosphate buffer mixture (55: 45, v/v) of pH 4.0. The mobile phase was pumped at a flow rate of 1 mL/min with ultraviolet detection at 255 nm. The selectivity, linearity of calibration, accuracy, intra and inter day precision and recovery were examined as parts of the method validation. The concentration– response relationship was linear over a concentration range of 0.50-10.00 and 5.00-50.00 μg/mL for ASC and SAL, respectively with limits of detection of 0.048 and 0.676 μg/mL. The proposed method was applied for the simultaneous determination of the two studied drugs in their combined tablets with average recoveries of 100.04 ± 0.75% and 100.11 ± 1.04% for ASC and SAL, respectively. The results were favorably compared to those obtained by the comparison methods.