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摘要
Stability-indicating LC methods using a UV detector and a charged aerosol detector (CAD) simultaneously were validated for the assessment of alogliptin (ALG) in tablets. The analysis was performed on a C-8 column (250 x 4.6 mm, 5 mu m) at a flow of 0.8 mUmin, using acetonitrile-10 mM ammonium acetate buffer (pH 3.5; 90 + 10, v/v) as mobile phase and UV detection at 275 nm. Validation followed the International Conference on Harmonization guidelines. The method was linear over the range of 25-200 mu g/mL. Normality of the residuals showed a normal distribution, no autocorrelation, and homoscedasticity. LODs were 6.25 and 2.65 pg/mL and LOQs were 20.85 and 8.84 mu g/mL for the CAD and the UV detector, respectively. The methods were precise and accurate. Excipients and degradation products did not interfere in the methods in studies of specificity. None of the factors studied in the analysis of robustness had a significant effect on the quantification of the ALG by the Pareto chart. The results of the assay obtained with LC CAD and LC UV were similar. The methods could be considered interchangeable and stability indicating, and can be applied as an appropriate QC tool for analysis of ALG in tablets.
- 出版日期2017-4
