摘要
目的：利用近红外光谱法建立盐酸地芬尼多片的定量分析模型。方法：采集盐酸地芬尼多片近红外光谱，采用偏最小二乘法（PLS）进行回归，通过建立近红外光谱与高效液相色谱（HPLC）法测定值之间的多元校正模型，预测盐酸地芬尼多片的含量。结果：33批样品HPLC法含量范围为19．36-26．65（mg／mg），近红外光谱谱段范围为7502-6800cm^-1，定量模型的内部验证决定系数R2为93．1，内部交叉验证均方根误差为0．51。结论：本方法快速、简便、对样品无损，结果准确，适用于药品的现场筛查及样品在流通过程中的质量监控。
OBJECTIVE： To develop the near infrared （NIR） quantitative models for the determination of Difenidol hydrochlo- ride tablets. METHODS： NIR diffuse reflectance spectra of the tablets were collected. Partial least square （PLS） was utilized to build the quantitative models with these spectra using HPLC as a reference method; multivariate calibration model was used to estimate the content of Difenidol hydrochloride tablets. RESULTS： The contents of 33 batches of the tablets were 19.36-26.65 （mg/ mg） and the spectral ranges were 7 502-6 800 cm^-1. The determination coefficients R2 were 93.1, and RMSECV was 0.51. CONCLUSIONS： The method is rapid, simple and accurate, and doesn＇t damage the samples. It can be used for the field screening and quality control of the samples under circulation process.
出处
《中国药房》
CAS
CSCD
2014年第25期2352-2354,共3页
China Pharmacy
关键词
盐酸地芬尼多片
近红外光谱
偏最小二乘法
定量模型
Difenidol hydrochloride tablets
Near infrared
Partial least square
Quantitative model
作者简介
副主任药师，硕士。研究方向：药品质量分析及其不良反应研究。E-mail：romnriquelme@163．com
