Validated capillary electrophoretic method for the quantitative analysis of histamine acid phosphate and/or benzalkonium chloride.

A novel capillary electrophoresis method has been developed and validated for the quantitative determination of histamine acid phosphate (HAP) and/or benzalkonium chloride (BKC). The solutes were separated using a pH 2.5 phosphate electrolyte with detection at 200 nm. Acceptable precision was obtained using internal standardisation. The method was also acceptable for determining levels of histidine which is an impurity in HAP. Profiling of BKC homologues was demonstrated for batch identity purposes. This method is used routinely and it is intended to register this method in the British Pharmacopoeia to supplement current test methods of TLC and HPLC.