A rapid and validated reverse phase liquid chromatographic method for determination of imiquimod from topical cream formulations

A Novel, rapid, accurate and precise reverse phase isocratic HPLC method has been developed for the determination of Imiquimod content in Imiquimod cream which is widely used for treatment of precancerous skin lesions known as actinic keratosis, a certain type of skin cancer and treatment of genital warts, known as Human Papilloma Virus (HPV). A mixture of 10 mM monobasic phosphate containing 0.1% triethylamine adjusted to pH 2.45 and acetonitrile in the ratio of 70:30 (v/v) was used as mobile phase. C-18 column of dimension 250 × 4.6 mm, 5 μ from Inertsil was used for analysis. Detector wavelength was kept at 245 nm and flow rate was kept 1.4 mL min−1. The retention time was observed at about 3.0 ± 0.1 min. The method has been validated as per ICH guidelines, with respect to specificity, linearity, accuracy, precision, robustness, solution stability and filter compatibility. Results for all the parameters were found within predetermined limits. The proposed method was applied to determine the content of Imiquimod in Imiquimod creams from different manufacturers. Content of the imiquimod was in good agreement with label claim of Imiquimod creams. This showed that proposed method is rapid, simple, precise, linear, robust, rugged and accurate which is useful and economic for routine analysis of Imiquimod content in Imiquimod cream.