关键词：
High performance liquid chromatography
摘要：
Fourier transform infrared spectroscopy (FTIR) is a widespread technique that can provide a chemical signature (fingerprints) of solid, liquid, or gas samples with a wide range of analytical applications. High-performance liquid chromatography (HPLC) is a leading analytical strategy for pharmaceutical analysis. Here we present a side-by-side comparison of the potential of these techniques for quantitative analysis of pharmaceutical active ingredient combinations in light of green analytical chemistry (GAC) principles. The methods were successfully applied for the analysis of ketoprofen (KTP)/hyoscine (HYS) and benzocaine (BENZ)/dextromethorphan HBr (DEX) in their binary mixtures and pharmaceutical preparations. In FTIR analysis, calibration models were constructed based on partial least squares regression (PLSR) with satisfactory regression coefficients (r(2)) of 0.9998, 0.9994, 0.9855, and 0.9895 for KTP, HYS, DEX, and BENZ, respectively, over a wide linearity range (10-100, 10-100, 5-75, and 10-100 mu g mL(-1)) that covers the concentration ratios in the market samples. External validation using a validation set and internal validation using leave-one-out-cross-validation calculations were performed, and small root-mean-square-error-of-cross-validation (RMSECV) values were obtained indicating the good resolving power of the models. The same performance was obtained using the HPLC method for separation of the same mixtures with r(2) equal to 0.9998, 0.9999, 0.9998, and 0.9998 over linear ranges of 50-1000, 10-200, 5-100, and 5-100 mu g mL(-1) for KTP, HYS, DEX, and BENZ, respectively. The HPLC methods were validated following ICH guidelines with good recovery percentages in the range of 98-100%. The statistical comparison of the FTIR and HPLC methods for analysis showed almost the same results with good applicability towards commercial dosage forms. Concerning the twelve GAC principles, a detailed comparison was performed to highlight the opportunities of each tech
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