The purpose of the research described herein was to develop and validate a reversed-phase liquid chromatographic (RPLC) method for the commercially available spermicides nonoxynol-9 (1.90-2.10%, w/w) in a gel formulation. The chromatographic separation was achieved with methanol-water (83:17, v/v) as mobile phase through a Nucleosil Cyano column by UV detection at 289 nm. The calibration curve was linear over the concentration range of 0.05-0.35 mg/mL (R2 = 0.9997). The recovery ranges were from 99.87-100.04% from a gel formulation. The mean percent relative standard deviation values for intra- and inter-day precision studies were less than 1.0%. The method was adequate sensitive with detection limit of 0.0065 ug/mL. The assay method remains unaffected by small but deliberate variations, thus it was robust.
Keywords: Spermicides, Nonoxynol-9, Gel formulation, RPLC, Method development, Method validation