Ultra HPLC method development and validation for the determination of meclizine in pharmaceutical formulation
Abstract
For meclizine, a straightforward, quick, and precise high-performance liquid chromatographic (HPLC) method is created, refined, and verified. Linearity, accuracy, and precision were the three criteria used to validate the method. In order to overcome the limitations of the UV approach for determining meclizine concentration, a novel technique called ultra-high-performance liquid chromatography (HPLC) was employed to measure the amount of meclizine in pharmaceutical samples. As a drug it used as antiemetic and for nausea which make it vital for use in different formulations. To assess the amount of meclizine in formulation a quick, easy and reproducible UHPLC method was used. Detection in the device was achieved using UV–A visible detector at a wavelength of 232 nm. A combination of acetonitrile and water (60:30) with 0.7 grammes of monobasic sodium phosphate per 100 mL was optimized to make up the mobile phase. Phosphoric acid was used to bring the pH down to 4. In isocratic mode, the analysis was performed with a 1.5 ml/min mobile phase flow rate. When meclizine was analyzed using UHPLC, it eluted with a distinctively sharp peak with a retention time of 7.6 minutes. The LLOQ, which is equivalent to 1.1 ±0.6 µg/mL, is the lowest concentration. A meclizine limit of detection (LOD) of 0.3 ± 0.5 µg/mL was found. For further research, the approach proved accurate and simple to set up.
Keywords: Meclizine, UHPLC, Calibration curve, Validation, Verification
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