DETERMINATION OF THE SPERMICIDE NONOXYNOL-9 IN VAGINAL LAVAGE BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY

A sensitive normal-phase high-performance liquid chromatographic metho d using a bonded-phase aminosilica column has been developed for the m easurement of the spermicide nonoxynol-9 in vaginal lavage fluid. The mean multiple correlation coefficient (r(2)) for nonoxynol-9 was 0.999 over the calibration range 3.125-50 mu g/ml for the standards. Qualit y control samples measured at two different concentration levels gave intra-day precision values (coefficient of variation, C.V.) in the ran ge of 0.61 to 1.63% and the intra-day accuracy values (mean relative e rror, M.R.E.) in the range of 0.13-0.62%. Inter-day precision and accu racy values from five different calibration standard concentration val ues ranged from 2.25 to 5.09% C.V. and 4.02 to 7.56% M.R.E. Nonoxynol- 9 samples examined for peak area stability at room temperature over a 24-h time period had a M.R.E. of 14.9%. Quality control samples stored at -70 degrees C, and tested after one month by comparison to baselin e samples, had a M.R.E. of -10% and -7.53% for the low and high qualit y control samples, respectively. The method is sensitive and simple, w ith short runtimes, to enable the processing of numerous samples from a clinical trial.