盐酸左氧氟沙星片的近红外光谱法快速检测

Rapid Detection of Levofloxacin Hydrochloride Tablets with NIR Spectroscopy

建立了近红外光谱(NIR)法快速测定盐酸左氧氟沙星(1)片的含量。按照处方工艺自制了50批1片试验样品,并收集了10批1片。以高效液相色谱法测定值为参考值,运用偏最小二乘法(PLS)建立NIR法测定1含量的校正模型。选取5 526.7～6 187.5 cm^(-1),5 003.6～5 389.1cm^(-1),4 466.8～4 700.8 cm^(-1)谱段,采用一阶导数+矢量归一化(FD+VN)方法预处理,建立了1片的NIR定量模型。定量模型校正集和验证集的R^2为0.999 4和0.998 2,RMSECV为2.29和2.43,预测结果偏差为-1.23～1.03 mg/g。t-检验结果表明,NIR法的预测值与参考值无显著性差异。该方法简便快速、结果准确,可用于1片的快速检测。

A near-infrared spectroscopy（NIR） method was established for the determination of levofloxacin hydrochloride（1） tablets. Fifty laboratory samples were prepared according to the prescription of 1 tablets and 10 batches of industrial samples were collected. A quantitative calibration model was established by NIR combined with partial least square（PLS） regression, taking the contents determined by HPLC as the reference values. The quantitative calibration model of 1 was successively established. The original spectrum of samples were pretreated by FD＋VN technology, and the spectra in the ranges of 5 526.7-6 187.5 cm^（-1）, 5 003.6-5 389.1 cm^（-1）, and 4 466.8-4 700.8 cm^（-1） were chosen for analysis. The R^2 and RMSECV of the calibration set were 0.999 4 and 2.29, while that of the validation set were 0.998 2 and 2.43, respectively. The error was-1.23-1.03 mg/g. Furthermore, a paired t-test was performed to confirm that the NIR values and the reference values have no significant difference. The method is simple, rapid, and can be applied to rapid detection of levofloxacin hydrochloride tablets.