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.
Highlights
Extended-release systems provide drug release in an amount sufficient to maintain the therapeutic drug level over an extended period, with the release profiles predominantly controlled by the special technological construction and design of the system itself
Analytical methods were developed for analyzing galantamine hydrobromide in bulk as well as final formulations
The calibration curves of galantamine hydrobromide were prepared in pH 1.2, pH 4.5, pH 5.8, pH 6.8, pH 7.4 systems
Summary
Extended-release systems provide drug release in an amount sufficient to maintain the therapeutic drug level over an extended period, with the release profiles predominantly controlled by the special technological construction and design of the system itself. The development of oral extended-release systems has been a challenge to formulation scientists due to their inability to restrain and localize the system at targeted areas of the gastrointestinal tract. There are numerous products in the market formulated for both oral and parenteral routes of administration that claim extended or controlled drug delivery. Matrix-type drug delivery systems are one of the interesting and promising options in developing an oral extended-release system. This agent may improve neurocognitive function in mild and moderate Alzheimer' s disease and may reduce abstinence-induced cognitive symptoms that promote smoking relapse [7,8,9,10,11]
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