Determination of the spermicide nonoxynol-9 in vaginal lavage by high-performance liquid chromatography.
A sensitive normal-phase high-performance liquid chromatographic method using a bonded-phase aminosilica column has been developed for the measurement of the spermicide nonoxynol-9 in vaginal lavage fluid. The mean multiple correlation coefficient (r2) for nonoxynol-9 was 0.999 over the calibration range 3.125-50 micrograms/ml for the standards. Quality control samples measured at two different concentration levels gave intra-day precision values (coefficient of variation, C.V.) in the range of 0.61 to 1.63% and the intra-day accuracy values (mean relative error, M.R.E.) in the range of 0.13-0.62%. Inter-day precision and accuracy values from five different calibration standard concentration values 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 baseline samples, had a M.R.E. of -10% and 7.53% for the low and high quality control samples, respectively. The method is sensitive and simple, with short runtimes, to enable the processing of numerous samples from a clinical trial.
McPherson
J L
JL
Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, MD 21287-5554, USA.
Nichols
J H
JH
Barditch-Crovo
P
P
Hamzeh
F M
FM
D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D017137:Nonoxynol / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013048:Specimen Handling; D013050:Spectrometry, Fluorescence; D013089:Spermatocidal Agents / Q000032:analysis*; D007507:Therapeutic Irrigation; D014621:Vagina / Q000737:chemistry*
D013089:Spermatocidal Agents; D017137:Nonoxynol