A validated stability-indicating rp-hplc method for analysis of azelaic acid in pharmaceuticals

Abstract

The study is designed to develop a simple, rapid, selective and robust stability indicating reversed phase-high performance liquid chromatography method for quantitative analysis of azelaic acid in pharmaceutical preparations. The chromatographic separation and estimation of azelaic acid was carried out using a Waters high-performance liquid chromatography system employing Kromasil 100-5C18 column (250× 4.6 mm; 5 µm particle size) as a stationary phase. The mobile phase comprised of 75 volumes of sodium di-hydrogen orthophosphate (pH 3.5; 50 mM) and 25 volumes of acetonitrile, eluted at a flow rate of 1.2 ml/min. The eluents were monitored at 206 nm using 2487 dual wavelength ultra violet detector. The method was developed and validated in terms of stability as per International Conference on Harmonisation and Center for Drug Evaluation and Research guidelines. A linear relationship between peak area and concentration of azelaic acid was observed in a concentration range of 5-400 µg/ml (correlation coefficient, r2= 0.998). The method showed acceptable levels of precision (%RSD ≤2), accuracy (>96 % recovery), robustness (<10 % content difference) and stability (>96 % recovery) over varied environmental and laboratory conditions. The method was successfully applied for the determination of azelaic acid, extracted from three different batches of Aziderm® cream, which yielded a recovery of >97 %, indicated its applicability in routine analysis of azelaic acid in pharmaceutical preparations.