近红外漫反射光谱法非侵入式定量分析盐酸氨溴索片剂

A near-infrared diffuse reflectance analysis method for the noninvasive quantitative analysis of ambroxol hydrochloride tablets

目的 建立非侵入式检测盐酸氨溴索片剂待压颗粒、裸片及铝塑包装片的方法。方法 应用傅立叶变换近红外光谱仪和外接积分球、旋转测样器及固体光纤探头 ,颗粒样品采用PbS检测器 ,裸片及铝塑包装片采用InGaAs检测器 ,在 12 0 0 0～ 4 0 0 0cm- 1 ,每份样品扫描 6 4次求平均值 ,通过PLS法建立模型 ,待压颗粒、裸片、铝塑包装片建模采用波段分别为 4 6 0 2～ 4 2 4 7,12 0 0 0～ 74 98和 6 10 2～ 5 4 4 6 ,12 0 0 0～ 5 4 4 6cm- 1 。结果 交互证实法确定待压颗粒、裸片及铝塑包装片最佳主成分数均为 6 ,均方误分别为 0 30 6 ,0 972和 1 4 92。待压颗粒、裸片及铝塑包装片预示集主药盐酸氨溴索平均回收率分别为 10 0 % ,10 0 %和 10 2 % ,回收率RSD分别为 1 17% ,1 70 %和 1 78%。结论 近红外漫反射光谱法简便、快速、可靠 ,完全可应用于盐酸氨溴索片剂待压颗粒、裸片及铝塑包装片的快速无损定量分析 。

Aim To develop a near infrared diffuse reflectance analysis (NIRDRA) method for rapid noninvasive quantitative determination of ambroxol hydrochloride in half finished product particles and non blister packed, blistered tablets. Methods All spectra were measured with a Fourier transform spectrometer equipped with a PbS and a InGaAs detector, an external integrating sphere, a rotating sample cup, and a fibre optic probe for reflectance measurements. All samples were scanned from 12 000 cm -1 to 4 000 cm -1 , and each sample spectrum was obtained as an automatic mean of 64 scans. No spectrum pre processing method was used, and spectral regions, 4 602 - 4 247 , 12 000 - 7 498 and 6 102 - 5 446 , 12 000 - 5 446 cm -1 were selected to develope mathematical models by partial least square method for half finished product particles and non blister packed, blistered tablets samples, respectively. Results The optimal rank and mean square error determined for half finished product particles and non blister packed, blistered tablets samples by cross validation method all was 6 and 0 306, 0 972 and 1 492, respectively, the average recovery was 100%, 100% and 102% respectively; and the RSD was 1 17%, 1 70% and 1 78% respectively. Conclusion Results showed that the NIRDRA method was rapid, simple, noninvasive and sensitive, and it can be applied to assay the content of ambroxol hydrochloride in half finished product particles non blister packed and blistered tablets.