Determination of the content of pregabalin gastric retention sustained-release tablets and influence of high viscosity excipients on the determination results
A high-performance liquid chromatographic(HPLC)method for the assay of pregabalin gastric retention sustained-release tablets was established,successfully solving the problem of low recovery of pregabalin through a special sample pretreatment method.By comparing salting-out and excipient dispersion,the pretreatment methods to overcome the viscosity of the test solution were established.Both methods can be used for the determination of the product content,but the salting-out method is easier to operate.The HPLC conditions were Inertsil ODS-3(4.6 mm×0.25 m,5 µm)column with mobile phase of 3.4 g/L potassium dihydrogen phosphate(pH adjusted to 6.3 by ammonia)and methanol(85︰15);the column temperature was 30℃;the flow rate was 1.0 mL/min;the sample size was 50 µL;and the detection wavelength was 210 nm.Through the validation of the salting-out method,the average recovery of the drug was 99.74%and the RSD was 0.43%;the precision test RSD was 0.77%;the test solution was stable within 12 h;the chromatographic system had good durability;and the excipient did not interfere with the content detection.The method is stable,reliable and suitable for the assay of pregabalin gastric retention sustained release tablets.
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