ファーマシューティカ アナリティカ アクタ

概要

Validated HPLC Method for the Determination of Nisoldipine

Shaban A Abdulla, Manal A El-Shal and Ali K Attia

In this study, novel high performance liquid chromatography methods which are described as a simple, selective, sensitive, precise and simultaneous analysis of Nisoldipine in bulk and commercial tablet formulation containing Nisoldipine. Good chromatographic separation was achieved using a specific column Agilent ZORBAX Eclipse Plus C18, 4.6×250 mm and a mobile phase consisting of methanol, 0.01 M potassium dihydrogen phosphate aqueous solution and 0.1 M Hexane sulphonic acid sodium salt (25:65:10, v/v) at pH 4.0 using orthophosphoric acid with a flow rate of 1.0 ml/min. The ultraviolet detector was set at a wavelength of 275 nm. Nisoldipine was eluted at 7.43 min. Due to the high precautions taken during the analysis, no extraneous materials were found to interfere. The linear range for Nisoldipine was 5-30 μg/ml. The linearity, precision, accuracy, robustness, limit of detection and limit of quantification of the proposed method were determined. Regression coefficients (r2 ≥ 0.999), recovery (97.2- 103.1%), the limit of detection (0.4 μg/ml) and the limit of quantification (1.0 μg/ml) were validated and found to be satisfactory. The proposed method is convenient for quantitative routine analysis and purity control of Nisoldipine in its bulk powder and dosage forms.