Development and Validation of Stability-indicating RP-HPLC method for the simultaneous analysis of Salbutamol, Theophylline and Ambroxol
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2017, Vol 3, Issue 11
Abstract
Abstract:In pharmaceutical industry, researchers aim at catering to the need of robust analytical methods for analysis of generic drug products. A simple, novel and efficient stability indicating HPLC method has been developed in a multi component drug formulation for simultaneous estimation of Salbutamol, Theophylline and Ambroxol in presence of their degraded products. This HPLC method uses Inertsil ODS C18 column HPLC column, phosphate buffer pH 6.3 and Methanol: Water: Acetate Buffer 60:35:05 v/v as mobile phase in isocratic mode with UV detection at 239 nm. The method was validated and found to be precise, robust, accurate, linear (range of 1‐6μg/ ml, 50-300 μg/ ml and 15‐90 μg/ ml for Salbutamol, Theophylline and Ambroxol respectively), and specific for degraded products ensuring suitability of the method for quantitative determination of Salbutamol, Theophylline and Ambroxol. The method is stability-indicating, and therefore qualified and reliable for demonstrating and detecting any expected change or degradation in the drug product during stability studies. The method developed here is found to be novel, robust and rugged enough to reproduce accurate and precise results under different method conditions. Keywords:Pharmaceutical formulation; HPLC method; Salbutamol; Theophylline; Ambroxol; Validation; Stability indicating method
Authors and Affiliations
L. Kalyani, Chava V N Rao
Keywords
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