Method development and validation of spray content uniformity for ipratropium bromide and budesonide in nasal spray

Abstract

Ipratropium bromide and Budesonide is combined Pharmaceutical Nasal dosage form. The label claim of this combined dosage form is 21 mcg of Ipratropium Bromide and64 mcg of Budesonide per Spray. It is for treatment of allergic rhinitis. Spray content uniformity is in-vitro investigational test which provides idea of uniformity of product throughout product life cycle. The present study aimed to validate High Performance Liquid Chromatography method for determination of spray content uniformity of these analytes. This validation study performed as per guidelines of International Conference on Harmonization and covers Precision, Linearity, Accuracy, Robustness, Ruggedness, stability of analytical solution and Specificity. The reversed phase chromatographic method uses a mobile phase prepared by mixing Buffer containing Sodium dihydrogen orthophosphate with Acetonitrile, Zorb ax CN150 mm column, 1.5 ml per min flow rate, 220 nm wavelength, 25°C column oven and 50 μL injection volume. The method found linear over the range of 50% to 150% of target concentration with correlation coefficient of 0.9997 for Ipratropium bromide and 0.9999 for Budesonide. The recoveries obtained were 103.1% - 103.8% for Ipratropium bromide and 97.0% - 100.1% for Budesonide. %Related Standard Deviation found well within the acceptance criteria for precision. No interference found at the retention time of analyte peaks in blank, placebo and degradation conditions describe specificity of method. The method showed a successful application for determination of Ipratropium bromide and Budesonide in Nasal spray pharmaceutical formulation.