Development and Validation of Stability-indicating RP-HPLC Method for The Estimation of Pseudoephedrine, Ambroxol and Desloratadine in Bulk and Their Tablet Dosage Forms
Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Kakinada, 1Department of Pharmaceutical Analysis and Quality Assurance, Andhra University, Visakhapatnam, India.
Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Kakinada, India. E-mail: [email protected]
A simple, accurate, selective and stability-indicating RP-HPLC method was developed for the simultaneous estimation of pseudoephedrine, ambroxol and desloratadine in bulk and their tablet formulations. Effective chromatographic separations were achieved on a Hypersil BDS C8, 250×4.6 mm, 5 μ column with reverse phase elution. The mobile phase composed of 0.01 M potassium dihydrogen phosphate and acetonitrile in the ratio of 50:50 v/v at a flow rate of 1.0 ml/min. The detection was carried out at 220 nm. The retention times were 2.2 min for pseudoephedrine, 3.4 min for ambroxol and 5.5 min for desloratadine. The linearity ranges for pseudoephedrine, ambroxol and desloratadine were 15 to 90 μg/ml, 30 to 180 μg/ml and 2.5 to 15 μg/ml, respectively with correlation coefficient 0.999. The developed method was validated statistically with respect to linearity, range, precision, accuracy, specificity, robustness, ruggedness, detection and quantification limits and also subjected to stress conditions like acidic and alkaline hydrolysis, oxidation, photolysis and thermal degradation. The method was accurate, precise, specific, rapid and found to be suitable for the analysis of commercial samples.