HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SALBUTAMOL SULPHATE

Abstract

Analytical method development helps to understand the critical process parameters and to minimize their influence on accuracy and precision. High Performance Liquid Chromatography is a technique in analytical chemistry used to separate, identify, and quantify each component in a mixture. The new HPLC method was developed and validated for estimation of salbutamol sulphate in pharmaceutical dosage form. This method has provided adequate separation for salbutamol sulphate from their impurities and degradation products. Separation was obtained by using a Kromasil (125 * 4.0nm) C-18 column at 40˚C temperature and using a mobile phase buffer (pH 3.7). Acetonitrile in the ratio of (815:185) at a flow rate 1.0 mL/min and wavelength for detection was 210 nm. Three replicate samples were taken to calculate % assay of ipratropium bromide and salbutamol sulphate. The % mean assay of the drug was found to be 116.4%. The linearity of developed method was achieved in the range of 1-25 μg/mL (r2=0.9999) for salbutamol sulphate. The proposed analytical method development and estimation of salbutamol sulphate and its validation by HPLC is accurate, precise, simple, selective, sensitive and rapid, hence this method can be effectively used for analysis of salbutamol sulphate in pharmaceutical dosage form.