Development and Validation of a Method for Quantitative Determination of Kemantane Drug Substance by Gas Chromatography

A new technique for quantitative determination of the active ingredient in pharmaceutical drug substance kemantane (5-hydroxyadamantan-2-one) using gas chromatography with a flame-ionization detector (GC-FID) was developed and validated. The solution. Bromophenol blue was performed on a WCOT fused silica capillary column (CP-WAX 52 CB, 50 m × 0.32 mm, 1.2-mm-thick layer of stationary phase). The optimum parameters of the chromatographic system and robustness factors of the technique were determined. The technique was validated with respect to the main parameters. Several batches of pharmaceutical kemantane drug substance were analyzed.