POTENT HORMONES IN THE AIR OF WORKPLACE IN THE PHARMA INDUSTRY: HPLC METHOD DEVELOPMENT FOR SIMULTANEOUS TRACE DETERMINATION OF CONTRACEPTIVES: ETHINYL ESTRADIOL, DROSPIRENONE, CYPROTERONE ACETATE. AND DESOGESTREL.

An HPLC method for the simultaneous trace determination of the hormones: ethinyl estradiol, drospirenone, cyproterone acetate and desogestrel or their combinations in the production area in factories has been developed. Adequate chromatographic peaks separation, resolution, sensitivity, and short analysis time (8 minutes) of the hormones was achieved using the selective SB Phenyl (5.0 cm x 4.6 mm, 3.5jj.m) column. Isocratic elution employing potassium dihydrogen phosphate buffer solution (pH= 6.0) with acetonitrile in a ratio of (50:50% v/v) delivered at a flow rate of 1.0 ml/min was achieved. Detection of targeted hormones was achieved simultaneously by using a UV detector and a fluorescence (FLD) detector in series. The validated method was found to comply with the international conference on harmonization guidelines (ICH). Each of the four studied hormones showed linearity in the range 0.02-64.00 jig/ml with limits of detection ranging from 0.0003 to 0.002 jig/ml and percent recoveries ranging from 67.4 % to 100.60%. For the assurance of the occupational health and safety of the workers, the developed method has been adapted to determine traces of residual hormones in the production area air of the cleaned production facility at Hikma pharmaceutical company in Amman/Jordan. It was applied successfully in the quality control laboratory after production of commercial products containing a combination of ethinyl estradiol and drospirenone. The production facility was considered clean based on the results that were found to be lower than limits of quantitation and within the accepted occupational exposure limits (OEL). [ABSTRACT FROM AUTHOR]