Development and Validation of Method for Determination of Clobetasol Propionate and Salicylic Acid from Pharmaceutical Dosage Form by HPLC

Aim: A new reverse phase high performance liquid chromatography (RP-HPLC) method for the quantitative determination of Clobetasol Propionate and Salicylic Acid in ointment was developed and validated as per ICH (International Conference on Harmonization) guidelines.

Methodology: Separation of Clobetasol Propionate and Salicylic Acid was achieved on Zorbax Eclipse XDB-C18 (250 mm x 4.6 mm, 5m) stationary phase by using mobile phase solution A, solution B and solution C (Solution A, B and C was composed of potassium dihydrogen phosphate, methanol [HPLC grade] and Acetonitrile [HPLC Grade]) with gradient flow rate. The injection volume and temperature of the column oven were 20µl and 30ºC± 2ºC respectively.

Results: The developed method shows high specificity for Clobetasol Propionate and Salicylic Acid. The calibration curve for Clobetasol Propionate and Salicylic Acid was linear and correlation coefficient (r2) for Clobetasol Propionate and Salicylic Acid was 1.0000 & 0.9999 respectively. The proposed method was adequate selective, reproducible and specific for the determination of Clobetasol Propionate and Salicylic Acid from ointment. Average percent of recovery for the drugs Clobetasol Propionate and Salicylic Acid were found 100.33% and 100.62% respectively. All of the results are within the acceptance criteria.

Conclusion: The proposed method was accurate and precise for the quantification of Clobetasol Propionate and Salicylic Acid in the ointment, also be used for routine analysis in quality control. The method parameters like selectivity, precision, intermediate precision, accuracy, linearity, recovery and stability was validated.