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摘要
A novel stability-indicating HPLC method was developed and validated for quantitative determination of sotalo-lHCl in bulk powder and in tablets. Isocratic HPLC method, using a C-18 reversed phase column with mobile phase of 80 mM potassium dihydrogen phosphate and acetonitrile (90: 10, V/V) was investigated to separate the drug from its stress degradation products. The flow rate was 0.8 mL/min, column oven temperature was ambient and detection was performed at 227 nm. Sotalol-HCl was subjected to the stress conditions of hydrolysis (acid and base), oxidation and photolysis. Stress degraded samples were analyzed by the developed procedure. The analyte was well separated from its degradants. The described method showed excellent linearity over a range of 5-100 mu g/mL. The determination coefficient (R-2) for sotalol-HCl was 0.9999. Limits of detection and quantification were 1.8 mu g/mL and 5 mu g/mL, respectively. Degradation of sotalol-HCl was observed in acid and in 30% H2O2 conditions only. The drug was found to be stable in the other stress conditions attempted. The percentage recovery of sotalol-HCl ranged from 98.92 to 99.65% in tablets. The developed method was validated with respect to the linearity, accuracy (recovery), precision, specificity and robustness. The forced degradation studies proved stability indicating power of the method.
- 出版日期2016
