Abstract
Introduction: The majority of analytical methods used currently to quantify Vitamin B6 are time-consuming, costly, non-environment friendly and destructive with respect to the analyzed material.
Objective: The objective of this study was to elaborate a novel method of vitamin B6 quantification in commercial pharmaceutical preparations using Near Infrared Spectroscopy (NIRS).
Methods: Powdered tablets and calibration samples containing pyridoxine hydrochloride and microcrystalline cellulose or lactose were employed. The raw NIRS spectra of calibration samples and tablets were transformed by Multiplicative Scatter Correction (MSC) or by second derivative normalization and used to generate the appropriate calibration plots. Alternatively, determination of pyridoxine hydrochloride was performed by Principle Component Regression (PCR) for powdered tablets and calibration sets of samples. The relationship was established between the Principal Component PC1 calculated for the selected ranges of pretreated NIRS reflectance spectra of calibration standards and the contents of pyridoxine hydrochloride.
Results: The samples of 3 different preparations containing 10 or 50 mg of pyridoxine hydrochloride that differed in composition of the excipients were analyzed. Depending on the composition of the formulation used and the selected wavelength range, the best recoveries for tested preparations were between 100-102%.
Conclusion: In this study we have proved that quantification of hydrochloride pyridoxine in solid pharmaceutical preparations by Near Infrared Reflectance Spectroscopy may be achieved with high precision and accuracy. Our method is cheap, rapid, environmentally-friendly and may be used for routine analyzes in the Quality Control laboratory.
Keywords: NIR spectroscopy, PCR, B6, Pyridoxine hydrochloride, Determination, Tablets.
Graphical Abstract
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