Cleaning Method: A Validated HPLC method for Determination of Clobetasol Propionate Residues on the Surface of Manufacturing Equipment

Cleaning validation is required in the pharmaceutical field to avoid potential clinically significant synergistic interactions between pharmacologically active chemicals. A simple, sensitive and accurate HPLC method has been developed and validated for determination of Clobetasol Propionate residues on the surface of manufacturing equipement. Separation of Clobetasol Propionate and Related compound A was achieved on Zorbax SB C18 (250 × 4.6 mm, 5 μ) stationary phase by using mobile phase (pH 2.5 Phosphate buffer: Methanol (20: 80), % v/v) at flow rate of 1.0 ml/minute. Clobetasol Propionate was detected at 240 nm. Method was linear in the concentration range of 0.07–30 μg/ml. RSD of the six replicates results (Precision) was found to be 2.73%. The swabbing procedure was optimized to achieve suitable recovery of Clobetasol Propionate from stainless steel surfaces. Recovery of the method was found > 85%. This method can be used to determine trace levels of Clobetasol Propionate residues in production equipment area to confirm the efficiency of the cleaning procedure in pharmaceutical industries to avoid cross contamination. © 2011 Universal Research Publications. All rights reserved