科研之友
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摘要
A dissolution test for tablets containing 100 mu, of lamotrigine was developed and validated. The dissolution test was applied to compare the dissolution profile of Neural (R) with the reference product Lamictal (R). The analysis procedure was carried out using a simple ultraviolet method at 267 nm. Alter the determination of solubility and sink conditions, the parameters selected were paddles at 50 rpm, 900 m L of 0.01 M hydrochloric acid, and 30 minutes duration (single point). This method was validated for specificity, linearity, accuracy, precision and robustness. Lamotrigine stability was also evaluated in dissolution medium.
- 出版日期2010-6
