Simple Hplc Method Development for the Estimation of Galantamine Hydrobromide in Extended-Release Formulation

Abstract

For the determination of Galantamine Hydrobromide in bulk and produced extended formulation, a new sensitive and quick HPLC technique was developed and validated according to ICH guidelines. The HPLC analysis was carried out using a waters system with a Thermo Scientific C18 (steel column (5 µm, 250mm × 4.6 mm)) column and a mobile phase of 0.1M phosphate buffer: Acetonitrile (40:60V/V) pH adjusted to 4.5 with orthophosphoric acid, at a flow rate of 1.0 mL/min. The detection was done at a wavelength of 203 nm, and galantamine hydrobromide had a retention time of 8.0 minutes. Over the concentration range of 1-10 g/ml, the calibration plot revealed a linear relationship. The accuracy of the proposed method was determined by recovery studies and was found to be near to 100 and % RSD value was found less than 2. The repeatability testing for both standard and sample solutions showed that the method is precise within the acceptable limits. RSD % of the determination of precision was <2%. The proposed method showed excellent linearity, accuracy, precision, specificity, robustness and system suitability results within the acceptance criteria. In addition, Saturation solubility of Galantamine Hydrobromide was determined in different pH mediums and it was found that Galantamine Hydrobromide has pH-dependent solubility, freely soluble in alkaline pH, and insoluble in acidic pH.