Development and validation of analytical method by RP-HPLC estimation of Goserelin acetate in biodegradable microspheres

Abstract

A simple, rapid, accurate and sensitive method was developed for quantitative analysis of Goserelin acetate in biodegradable microspheres formulation using reversed-phase high-performance liquid chromatography (RP-HPLC). The analysis is carried out using a reversed-phase C18 column with UV-Vis detection at 220nm. The isocratic mobile phase was phosphate buffer (pH7.4): acetonitrile in the ratio of 70:30 v/v at a flow rate of 1mL/min and column temperature maintained at 35°C. The developed method was validated according to the International Conference on Harmonisation (ICH) guideline with respect to system suitability, accuracy, precision, specificity, linearity and robustness. The linearity in the range of 2.5-90µg/mL presents a correlation of coefficient 0.999. The presence of components of the microspheres did not interfere in the results of the analysis. The method showed adequate precision, with a relative standard deviation (RSD) ≤ 2.0. The method was found to be suitable for routine quality control assay for encapsulated Goserelin acetate in biodegradable microspheres formulation was developed and validated.