An HPLC/CAD method for determination of fatty acids in metered dose inhalation products: a candidate leachable test method

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 proved to be an effective stationary phase for chromatographic separation. The mobile phase was determined to be a gradient system, comprising mobile phase A (0.5 mL of formic acid in 1000.0 mL of pure water) and mobile phase B (0.5 mL of formic acid in 1000.0 mL of acetonitrile). The standard solution was stable for 48 hours at 10 degrees C and the sample solution was stable for 3 hours at 10 degrees C.