Abstract
The use of near infrared (NIR) spectroscopy to predict the concentration of two active pharmaceutical ingredients (APIs), paracetamol and caffeine, in intact tablets, has been evaluated in this study. A partial least squares (PLS) regression model was developed using spectral data obtained on a calibration set consisting of 28 formulations containing 80, 90, 100, 110 and 120% of each API. Regression models were developed for each API, both using un-processed spectral data as well as after applying various spectra pre-processing methods. Cross-validation was used to select best calibration model. The selected model was validated in terms of precision, trueness, accuracy and linearity in a concentration ranging from 90 to 110% of the targeted APIs concentration. The applicability of the method was tested on tablets containing 300 mg paracetamol and 30 mg caffeine as targeted composition, and the API content predicted by the proposed NIR-chemometric method was not statistically different from the one obtained by HPLC method, used as a reference method. Thus, the method presented in the current paper is a step forward towards the implementation NIR as useful tool for monitoring the manufacturing process of fixed-dose combination tablets with paracetamol and caffeine.
Highlights
Tablets containing paracetamol and caffeine are used for the temporary relief of pain, being available as fixed-dose combination products
This method has been recognised by the European Directorate for the Quality of Medicines, which introduced in 2014 a dedicated monograph in the European Pharmacopoeia [2]
We have reported in a previous work the development and validation of a near infrared (NIR)-chemometric method as a suitable tool for prediction of paracetamol and caffeine in the powder blend for tabletting, in view to determine the blend uniformity during mixing steps of the manufacturing process [24]
Summary
Tablets containing paracetamol and caffeine are used for the temporary relief of pain, being available as fixed-dose combination products. Some papers report the simultaneous determination of physical and pharmaceutical properties of tablets by NIR, such as hardness, disintegration time and drug dissolution [19,20,21,22,23]. We have reported in a previous work the development and validation of a NIR-chemometric method as a suitable tool for prediction of paracetamol and caffeine in the powder blend for tabletting, in view to determine the blend uniformity during mixing steps of the manufacturing process [24]. The method presented in the current paper is a step forward towards the implementation NIR as useful tool for monitoring the manufacturing process of fixed-dose combination tablets with paracetamol and caffeine
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