Abstract
A hydrophobic interaction HPLC method was developed and validated for the analysis of human growth hormone (hGH) preparations. Separations were carried out on a TSK-Phenyl 5PW column using a descending linear gradient of 100% 1M ammonium phosphate dibasic/n-propanol (99.5:0.5), pH 8.0 to 100% 0.1M sodium phosphate/n-propanol (97.5:2.5), pH 8.0 over 30 minutes. The method proved highly reproducible for retention times, peak areas and peak heights, and the detector response for the main peak was linear between 1 and 1000 μg hGH/mL. Under these conditions, several hGH variants were resolved from the main hGH peak. A number of hGH preparations including the first WHO International Standard for hGH of pituitary origin and the new International Standard for hGH of recombinant origin were analysed. Of particular interest was the detection of a major impurity in the latter preparation. This impurity could not be detected by other conventional chromatographic or electrophoretic techniques. The same preparations were also analysed using a previously reported, neutral pH reversed phase HPLC method. A comparison of the impurity profiles detected by the two methods demonstrated that they have complementary selectivities.
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