Original Article A rapid and validated reverse phase liquid chromatographic method for determination of imiquimod from topical cream formulations Madhusudan T. Bachute*, Shankar L. Turwale Karmveer Bhaurao Patil Mahavidyalay, Pandharpur, Dist. Solapur, Maharashtra 413304, India article info Article history: Received 11 August 2012 Accepted 16 November 2012 Keywords: HPLC Reverse phase Validation and imiquimod abstract 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 m 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. Copyright ª 2012, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights reserved. 1. Introduction Now day’s pharmaceutical industries are showing increasing interest in topical preparations i.e. creams, ointments, lotions, foams, gels and nasal sprays etc. For accurate analysis of any pharmaceutical dosage form, simple, rapid and reproducible analytical methods are required. Liquid chromatographic separation technique is a powerful analytical tool and most preferable analytical technique used in pharmaceutical industries. 1e6 The developed analytical method should be accurate, reproducible, robust, precise and commercially viable one. 7e9 To ensure all these parameters in a method, validation of the analytical method is required as per Inter- national Conference on Harmonization (ICH) guidelines. 8,9 Imiquimod cream is commonly used to treat genital warts, known as Human Papilloma Virus (HPV). 10 It is also used as * Corresponding author. Karmveer Bhaurao Patil Mahavidyalay, Pandharpur, Solapur University, Solapur, Maharashtra 413304, India. Tel.: þ91 8888531274 (mobile). E-mail address: mbachute@gmail.com (M.T. Bachute). Available online at www.sciencedirect.com journal homepage: www.elsevier.com/locate/JOPR journal of pharmacy research 6 (2013) 73 e77 0974-6943/$ e see front matter Copyright ª 2012, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jopr.2012.11.016