Journal of Chemical Metrology

Abstract: There is no universal method and validation parameters for leachable studies for potential impurities in a metered-dose inhalation drug in the pharmaceutical industry, and this study aims to develop a new method to determine the leachability analysis of some fatty acids (myristic, linoleic, palmitic, oleic, elaidic, stearic and arachidic acids) by HPLC/CAD that may leach from the valve portion of the product as potential impurities in metered dose inhalers. The method was found suitable for leachability analysis of fatty acids in metered dose inhalation medication by HPLC/CAD by changing the method parameters, instrument, and detector settings and validated by determining sensitivity, linearity, range, specificity, accuracy, and recovery. In the developed analytical method, the C18 column was found to be suitable as the stationary phase for chromatographic separation, and mobile phase components were determined to be a gradient system consisting of mobile phase A (0.5 mL formic acid in 1000.0 mL pure water) and mobile phase B (0.5 mL formic acid in 1000.0 mL acetonitrile). The standard solution was stable for 48 hours at 10°C and the sample solution was stable for 3 hours at 10°C. This study will fill an important gap in the determination of the leachability of the valve part of inhalation products and will make an important contribution to the evaluation of the effectiveness of packaging and storage systems in quality assurance processes in pharmaceutical products.