Liquid chromatographic determination of residual hydrogen peroxide in pharmaceutical excipients using platinum and wired enzyme electrodes.

Hydrogen peroxide (H(2)O(2)) is a chemically reactive reagent that can oxidize and degrade many pharmaceutical compounds under normal conditions. Unfortunately, H(2)O(2) is often introduced into pharmaceutical excipients during manufacturing and it may significantly affect the chemical stability of drugs in formulations. Thus, a sensitive analytical method for determination of residual H(2)O(2) in excipients is of importance in formulation development and product quality control. A liquid chromatographic system with a dual channel electrochemical detector (LCEC) was equipped with either a platinum electrode or a wired peroxidase electrode for determination of H(2)O(2). The excipient (0.1 g) was dissolved in 10 ml of mobile phase and 5 microl of the dissolved solution was directly injected. The chromatographic run time for each sample was 1 min with a detection limit of 10 ng/ml (S/N=5) using the platinum electrode and 1 ng/ml (S/N=5) using the wired enzyme coated electrode, respectively. The peak purity was assured by comparing the peak ratios at different potentials for both the standard and the samples. The H(2)O(2) levels in different batches of PVP, PEG, and other surfactants from different manufacturers were determined and the values ranged from 0 to 244 ppm. The LCEC method is exceptionally fast, accurate and convenient for quantitation of low levels of residual H(2)O(2) in pharmaceutical formulation excipients.