DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ALBUTEROL SULPHATE AND IPRATROPIUM BROMIDE IN NASAL INHALATIONS

Abstract

A new RP-HPLC method was developed and validated for the simultaneous assay of albuterol sulphate and ipratropium bromide in nasal inhalations. The separation was performed on a non-polar peerless basic C8 column using a mixture of anhydrous potassium dihydrogen orthophosphate, 1-pentane sulphonic acid sodium salt monohydrate (pH 4.0) and acetonitrile (95:5 v/v) along with a mixture of anhydrous potassium dihydrogen orthophosphate, 1-pentane sulphonic acid sodium salt monohydrate (pH 4.0) and acetonitrile (70:30 v/v) as mobile phase in gradient elution mode. The retention time for albuterol sulphate and ipratropium bromide was at 2.927 ± 0.25 min and 10.479 ± 0.76 min. and the analyte peaks were analysed at 276 nm. and 220 nm. respectively over a run time of 22 minutes. The method obeyed linearity in the range of 0.0100 – 0.2080 mg/mL and 0.0023 – 0.0468 mg/mL for albuterol sulphate and ipratropium bromide respectively and the low coefficients of variation obtained in the intraday (0.8 % – 1.0 %) and inter day precision (1.1 % – 1.4 %) study are indicative of the precision of the method. High recovery of albuterol sulphate (98.0 – 102.0 %) and ipratropium bromide (98.1 – 101.9 %) indicate the accuracy of the method. The proposed method was also applied for the forced degradation studies on the drugs in respules and the system suitability parameters are within the acceptable limits. Therefore, the proposed method can be used for routine quality control of albuterol sulphate and ipratropium bromide in pure samples and dosage forms.