Simultaneous determination of some water-soluble vitamins and preservatives in multivitamin syrup by validated stability-indicating high-performance liquid chromatography method.
HPLC stability-indicating method has been developed for the simultaneous determination of some water-soluble vitamins (ascorbic acid, thiamine hydrochloride, riboflavin-5'-phosphate sodium, pyridoxine hydrochloride, nicotinamide, D(+)-panthenol) and two preservatives (methylparaben and sodium benzoate) in multivitamin syrup preparation. Water-soluble vitamins, preservatives and their degradants were separated on Zorbax SB-Aq (C(18)) (250 mm x 4.6 mm, 5 microm) column at an ambient temperature. Combined isocratic and gradient elution was performed with a mobile phase consisting of 0.0125 M hexane-1-sulfonic acid sodium salt in 0.1% (m/v) o-phosphoric acid, pH 2.4-2.5 (solvent A) and acetonitrile (solvent B) at the flow-rate 1 ml min(-1). Starting with solvent A an isocratic elution was performed for 15 min, then the composition was changed to 85% of A and 15% of B during the next 20 min and it was constant for 5 min, then the composition was changed to 70% of A and 30% of B during next 15 min and it was constant for 5 min and finally was changed to 100% of A as at the beginning of the elution. Detection was performed with diode array detector at 210, 230 and 254 nm. Multivitamin syrup preparation was subjected to stress testing (forced degradation) in order to demonstrate that degradants from the vitamins, preservatives and/or product excipients do not interfere with the quantification of vitamins and preservatives. Typical validation characteristics: selectivity, accuracy, precision, linearity, range, limit of quantification and limit of detection were evaluated for vitamins and preservatives.
Vidović
Stojanka
S
Galenika a.d., Batajnicki drum bb, 11070 Belgrade, Serbia. stvidovic@sezampro.yu
Stojanović
Biljana
B
Veljković
Jelena
J
Prazić-Arsić
Ljiljana
L
Roglić
Goran
G
Manojlović
Dragan
D
D001205:Ascorbic Acid / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D009536:Niacinamide / Q000032:analysis; D010205:Pantothenic Acid / Q000031:analogs & derivatives / Q000032:analysis; D010226:Parabens / Q000032:analysis; D011736:Pyridoxine / Q000032:analysis; D015203:Reproducibility of Results; D020160:Sodium Benzoate / Q000032:analysis; D012995:Solubility; D013831:Thiamine / Q000032:analysis; D014815:Vitamins / Q000032:analysis* / Q000737:chemistry; D014867:Water / Q000737:chemistry
D010226:Parabens; D014815:Vitamins; D014867:Water; D010205:Pantothenic Acid; C007288:dexpanthenol; D009536:Niacinamide; C015358:methylparaben; D011736:Pyridoxine; D020160:Sodium Benzoate; D001205:Ascorbic Acid; D013831:Thiamine