Simultaneous determination of Salbutamol sulphate anddoxophylline in tablets by reverse phase liquid chromatography

[摘要] A simple, isocratic reverse phase liquid chromatographic method has been developed and validated for simultaneous determination of Salbutamol Sulphate (SBS) and Doxophylline (DOX) present in tablet dosage forms. Chromatographic separation achieved isocratically on Luna C18 column (5 μm, 150mm x 4.60mm) and Acetonitrile/KH2PO4 buffer (40:60, v/v, pH 3.0 with OPA) as mobile phase, at a flow rate of 0.5 ml/min. Detection was carried out at 225 nm. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the ICH guidelines. The retention time for SBS and DOX was found to be 3.14±0.015and 5.73±0.06 min respectively. Linearity for SBS and DOX was in the range of 4-20 mg/ml and 400-2000 mg/ml respectively. The mean recoveries obtained for SBS and DOX were 98.54and 98.79% respectively and RSD was less than 2. The correlation coefficients for all components are close to 1. The relative standard deviations for three replicate measurements in three concentrations of samples in tablets are always less than 2%. Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of SBS and DOX in tablets.

[学科分类] 药理学