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Development and Validation of a Method for Simultaneous Quantification of Seven Water-Soluble Vitamins in Pediatrics Syrup by UPLC-MS/MS

[ Vol. 14 , Issue. 1 ]

Author(s):

Harmita, Herman Suryadi, Ati Setiawati and Dwi Damayanti*   Pages 23 - 34 ( 12 )

Abstract:


Background: Vitamin has an important function in biochemical processes and plays an important role in the main process of the human body. Vitamin products are used to maintain health, restore vitality, control weight and help in disease prevention. To comply with regulatory requirements and to establish nutrient intake in some populations, the quality of vitamins in food and nutritional supplements needs to be ensured.

Methods: This study aims to obtain a simultaneous method for the quantification of thiamine hydrochloride, riboflavin, nicotinamide, dexpanthenol, pyridoxine hydrochloride, cyanocobalamin and ascorbic acid in pediatric syrup by Ultra Performance Liquid Chromatography Tandem Mass Spectrometry (UPLC-MS/MS). ACQUITY UPLC® BEH Shield C8 column (2.1 mm x 50 mm, 1.7 m), mobile phase is a mixture of 10 mM ammonium formate in 0.2% formic acid pH 2.8 with methanol by gradient elution at a flow rate of 0.4 mL/min achieved in 6.5 minutes was used for separation. Ionization method was positive electrospray ionization (ESI +) with Multiple Reaction Monitoring (MRM).

Result: Confirmation result showed 7 water-soluble vitamin parent ions and daughter ion of thiamine HCl at m/z 265.15> 122; riboflavin at m/z 377.20> 243.10; nicotinamide at m/z 123> 80.10; pyridoxine HCl at m/z 170.10> 152.00; cyanocobalamin at m/z 678.45> 147.05; dexpanthenol at m/z 206.05> 76.00 and ascorbic acid at m/z 177.00> 94.90. The results of method validation showed that the method fulfills the acceptance criteria of precision, recovery and linearity

Conclusion: The method can be used for the routine analysis of determination of seven water soluble vitamins in pediatric syrup.

Keywords:

Water-soluble vitamins, UPLC-MS/MS, reversed-phase, development, validation, pediatric syrup, C8 column.

Affiliation:

Faculty of Pharmacy, Universitas Indonesia, Depok-Jawa Barat 16424, Faculty of Pharmacy, Universitas Indonesia, Depok-Jawa Barat 16424, National Quality Control Laboratory of Drug and Food, National Agency of Drug and Food Control, Jl. Percetakan Negara No 23 Jakarta Pusat, Jakarta, National Quality Control Laboratory of Drug and Food, National Agency of Drug and Food Control, Jl. Percetakan Negara No 23 Jakarta Pusat, Jakarta

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