RAPID ANALYSIS OF SOMATOSTATIN IN PHARMACEUTICAL PREPARATIONS BY HPLC WITH A MICROPELLICULAR REVERSED-PHASE COLUMN

A rapid high-performance liquid chromatography method for the analysis of somatostatin in pharmaceutical preparations is described. A commercially available column packed with 2 mu m spherical non-porous silica-based reversed-phase sorbent is used, along with a mobile phase consisting of acetonitrile and aqueous phosphoric acid, adjusted to pH 2.8 with sodium hydroxide. The effect of the organic modifier content and column temperature on the retention behaviour of somatostatin is reported. The method is found to be highly selective and specific, as indicated by the baseline separation of a mixture containing somatostatin and two analogue peptides, which differ from the analyte for one and two amino acids, respectively. Down to 10 ng of somatostatin can be detected and the detector response is linear over the concentration range from 4.14 to 20.75 mu g ml(-1). The application of this method to two commercial pharmaceutical formulations of somatostatin is found to give a mean percentage recovery from each of the two commercial samples, subjected to multiple injection analysis (n = 5), of 100.9% with a RSD of 0.92%, and 102.6% with a RSD of 1.56%, respectively.