Development And Validation Of A HPLC Method For Adapalene And Benzoyl Peroxide In Bulk And Gel

Abstract

The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of Adapalene and Benzyol peroxide in semisolid dosage form. The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The Sample recoveries in all formulations were in good agreement with their respective label claims. From literature review and solubility analysis initial chromatographic conditions Mobile phase ortho phosphoric acid buffer : Methanol (30:70) were set (Buffer pH 3 adjusted with opa ), symmetry C 18  (250×4.6mm, 5µ) Column, Flow rate 1.0 ml/min and temperature was ambient (30^oC), eluent was scanned with PDA detector in system and it showed maximum absorbance at 254 nm. As the methanol content was increased Adapalene and Benzyol peroxide got eluted with good peak symmetric properties. The retention times for Adapalene and Benzyol peroxide was found to be 2.972 min and 3.548 min respectively. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 50% to150 % levels, R² value was found to be as 1.0 & 0.999. By using above method assay of marketed formulation was carried out, 99.83% & 98.89% was present in “Persol Plus Gel” market available .label claim was each gram of adapalene and benzoyl peroxide gel 0.1% / 2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque, aqueous based gel.