COMPARISON OF FT-NIR TRANSMISSION AND HPLC FOR GREEN APPROACH TO DETERMINE PARACETAMOL AND ITS DEGRADATION PRODUCT 4-AMINOPHENOL IN PARACETAMOL TABLETS
Keywords:
Paracetamol, 4-Amino phenol, FT-NIR transmission, GAC (green analytical chemistry), HPLC assay, Validation, PLS modelAbstract
Objective: Development and validation of Near infrared (NIR) spectroscopic method for determination of paracetamol and its major degradation product 4-aminophenol in paracetamol tablets and show the agreement between the NIR as a greener technique and the conventional high performance liquid chromatography (HPLC) method, official in British pharmacopeia (BP).
Methods: Calibration model for paracetamol and its degradation product 4-aminophenol was built by utilizing chemometric processing which is the most critical step in the development of specific and robust NIR models. It is based mainly on a partial least square regression fit on the transmission mode using paracetamol, 4-aminophenol and excipient materials of the drug products. The results obtained by NIR spectroscopy were compared with the compendial HPLC method in the BP.
Results: The chosen models had a root mean square error of the cross validation (RMSECV) values of 1.38, 1.42 and coefficient of correlation (r2) of 99.1, 99.05 for paracetamol and 4-aminophenol respectively, which indicates good fitness and accuracy of the model.
Conclusion: The present study showed that NIR could be used with high accuracy for determination of for parent drug and its major degradation product in paracetamol tablets. This proposed technique realizes many of green analytical aspects in developing eco-friendly analytical methods and may replace safely the conventional chromatographic technique without compromising efficacy.
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