Abstract

A competitive CZE method for quality control analysis of multivitamin preparations and veterinary products containing B-group vitamins was developed. Vitamins of interest are thiamine hydrochloride (B1), thiamine monophosphate chloride (B1a), riboflavine (B2), riboflavine-5′monophosphate (B2a), nicotinamide (B3), d-pantothenic acid calcium salt (B5), pyridoxine hydrochloride (B6), folic acid (B9), and 4-aminobenzoic acid (B10). These analytes were separated optimizing the experimental conditions in 20 mM tetraborate buffer pH = 9.2 as a BGE (background electrolyte), on a Beckman P/ACE System MDQ instrument, using uncoated fused silica capillary. The effective capillary length was of 49.5 cm, I.D. = 50 μm, the applied voltage 20 kV and the temperature 25°C. Detection was performed by a diode array detector at 214 nm for all vitamins except B5 (190 nm) and B2a (260 nm). Separation time was about 9 min. After experimental conditions optimization, the proposed method was validated. Precision of migration time and corrected peak area, linearity range, LOD and LOQ, accuracy (recovery), robustness, and ruggedness were evaluated for each analyte demonstrating the good reliability of the method. Analyses of the pharmaceutical real samples were performed and confirmed the versatility of this method.

Highlights

  • Quality control (QC) plays an essential role in the pharmaceutical industry

  • A HPLC-UV method was established for the simultaneous determination of eight vitamins, including B1, B2, B3, B6, B9, cyanocobalamin, ascorbic acid in baby milk powder [3]

  • Simultaneous determination of water- and fatsoluble vitamins in pharmaceutical preparations by HPLC was performed in a single run using combined isocratic and linear gradient elution with a mobile phase consisting of trifluoroacetic acid and methanol

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Summary

Introduction

Quality control (QC) plays an essential role in the pharmaceutical industry. many analytical methods, employing different techniques, are being developed for evaluation of pharmaceutical preparations. A method for the simultaneous determination of taurine and 10 water-soluble vitamins including vitamin B1 (thiamine), B2 (riboflavine), B5 (pantothenic acid), B6 (pyridoxine and pyridoxal), B8 (biotin), B9 (folic acid), C (ascorbic acid), and B3 (nicotinamide and nicotinic acid) in multivitamin tablets was developed and validated. A HPLC-UV method was established for the simultaneous determination of eight vitamins, including B1, B2, B3, B6, B9, cyanocobalamin, ascorbic acid in baby milk powder [3]. A validated HPLC-UV method for the determination of seven B-complex vitamins (B1, B2, B3, B6, B9, and cyanocobalamin) in pharmaceuticals and biological fluids after solid-phase extraction was performed [4]. Simultaneous determination of water- and fatsoluble vitamins in pharmaceutical preparations by HPLC was performed in a single run using combined isocratic and linear gradient elution with a mobile phase consisting of trifluoroacetic acid and methanol. Vitamins analyzed were B1, B2, B5, B6, B9, B3, and B12 (cyanocobalamin) [5]

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