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Development and Validation of RP-HPLC-PDA Method for Estimation of Mometasone Furoate, Salicylic Acid, Methyl Paraben and Propyl Paraben in Combined Topical Formulation by Using Design of Experiment

Vishnu Choudhari, Savita Phadtare, Hanuman Gaikwad, Rushikesh Salunkhe, Ashish Galange

Objective: To develop simple, rapid and precise liquid chromatographic method for simultaneous determination of Mometasone furoate (MF), Salicylic acid (SA), Methylparaben (MP) and Propylparaben (PP) form pharmaceutical preparation. Methods: Isocratic separation of MF, SA, MP and PP was achieved using Kromasil C18 (250 × 4.6 mm, 5 µm) analytical column, mobile phase used was acetonitrile: 0.1 % acetic acid (60:40 % v/v) at flow rate of 0.8 ml/min. Column was maintained at 30 °C and detector was set at 264 nm. The analytes concentrations in sample were measured on weight basis to avoid the internal standard. The method is validated as per ICH analytical method validation guidelines. Results: Developed method was linear with correlation coefficient > 0.998 for all the analytes. The recovery values for MF, SA, MP and PP ranged from 98.56 – 101.70%, and % RSD was always less than 1.17. The ranges of the independent variables used for the optimization were ACN- 60-90%, Temp- 30-50 ºC and flow rate- 0.8-1.0 ml/min. The influences of these independent variables on the tailing factor (Tf) and resolutions (Rs) were evaluated. Using this strategy, mathematical model were defined and response surface were derived for the separation, responses were simultaneously optimized by using DOE. Conclusion: Optimised RP-HPLC-PDA method found to be accurate, precise, specific and economic with short run time. The method would be useful for both qualitative and quantative analysis of commercial formulations in pharmaceutical industry and research laboratories.