A Simple Stability Indicating CZE Method for the Analysis of Octreotide Acetate

Abstract

A simple stability indicating capillary zone electrophoretic method was developed and validated for the analysis of octreotide acetate (OCT-Ac). The best separation was achieved by bare fused silica capillaries (50 mu m i.d.; 65.5 cm total and 57.0 cm effective length), phosphate buffer (pH = 3.25; 50 mM), at 32.5 A degrees C. The samples were injected using 50 mbar for 5 s and subjected to the applied voltage of 27.5 kV for separation. The detection was carried out using a PAD at a wavelength of 195 nm. For improving the repeatability of the method, l-histidine was applied as an internal standard. According to the validation results, the method was linear in the concentration range of 3.30-400 mu g mL(-1) (correlation coefficient of 0.9996) with a limit of detection of 1.08 mu g mL(-1) and a limit of quantification of 3.30 mu g mL(-1); accuracy of the method was between 100.4 +/- A 0.2 and 101.1 +/- A 0.2 %; intra-assay precision was 0.5-2.6 % and intermediate precision was 1.3-3.2 %. The proposed method was successfully applied for the quantification of OCT-Ac in both a pharmaceutical formulation and force-degraded samples and for the detection and separation of degradation products; besides, the obtained results were used for the evaluation of the degradation kinetics of OCT-Ac under different stress conditions. So, it is concluded that the developed method could be employed as a simple, accurate and precise stability-indicating method in quality control laboratories to assess the quantity and stability of OCT-Ac pharmaceutical products.