研究目的
To develop and validate a near-infrared spectroscopic method for the simultaneous determination of clarithromycin, tinidazole, and omeprazole in Helicure tablets as an alternative to HPLC methods.
研究成果
The developed NIR method is accurate, precise, and efficient for simultaneous determination of clarithromycin, tinidazole, and omeprazole in Helicure tablets. It offers advantages over HPLC by being non-destructive, rapid, and environmentally friendly. The method is validated according to ICH guidelines and is suitable for routine pharmaceutical analysis.
研究不足
The method requires careful homogenization of samples to ensure reproducibility. It may be affected by variations in water content and excipient interference. The calibration range is limited to 80-120% of labeled content, and the method's performance depends on the selection of preprocessing techniques and variable selection methods.
1：Experimental Design and Method Selection:
The study used a multivariate calibration approach with partial least-squares regression (PLS) and genetic algorithm (GA) for variable selection. Reflectance near-infrared spectroscopy was employed for non-destructive analysis.
2：Sample Selection and Data Sources:
Samples included production samples from 10 batches and laboratory-prepared mixtures designed using D-optimal experimental design to span concentration ranges of 80-120% of labeled content.
3：List of Experimental Equipment and Materials:
Equipment included a Vector 22 N-T FT-NIR Spectrometer (Bruker), HPLC system (Hitachi LaChrome Elite), and software like OPUS Viewer, Matlab with PLS_Toolbox, and Design-Expert. Materials were pharmaceutical-grade standards and Helicure tablets.
4：Experimental Procedures and Operational Workflow:
NIR spectra were recorded in reflectance mode with specific parameters (32 scans, 2 cm-1 resolution, 12500-4000 cm-1 range). Samples were homogenized by grinding. Data preprocessing included SNV, MSC, and Savitzky-Golay derivatives. Calibration and validation sets were selected based on PCA.
5：Data Analysis Methods:
PLS models (PLS1, PLS2, GA-PLS1) were built and validated using cross-validation. Parameters like RMSECV and RMSEP were calculated for accuracy and precision assessment.
独家科研数据包，助您复现前沿成果，加速创新突破
获取完整内容
