Microdetermination of progesterone and testosterone in pharmaceutical preparations

ABSTRACT

A new method has been developed for the determination of micro- quantities of progesterone and testosterone in pharmaceutical preparations. The method does not involve prior extraction and showed an acceptable precision. The steroid is coupled with alkaline phosphatase linked to specific antibody, then free and bound fractions are separated by a magnetic technique and chromagen is added, followed by colorimetric measurement. The overall coefficient of variation [CV] was <10% for the 2 steroids. Analytical recovery was 98.7% for progesterone and 98.1% for testosterone. The results were valid and accurate, and the method correlated well with the British Pharmacopoeial method [BP] and radioimmunoassay [RIA] technique. Correlation coefficients were 0.97, 0.96, 0.95 and 0.91, respectively. The assay could be applied for determination of these drugs as single or batch samples using a simple colorimeter and magnetic separator