Simultaneous determination of chondroitin sulfate sodium, allantoin and pyridoxine hydrochloride in pharmaceutical eye drops by an ion-pair high-performance liquid chromatography.
An ion-pair high-performance liquid chromatography (HPLC) method has been developed for the simultaneous determination of chondroitin sulfate sodium (CSS), allantoin and pyridoxine hydrochloride (VB(6)) in a commercial eye drops dosage form. An Alltima C(18) column (250 mm x 4.6 mm i.d., 5 microm) was used for the separation at room temperature, with 25 mM ammonium dihydrogen phosphate (containing 0.01% heptanesulfonic acid sodium salt) and acetonitrile (95:5, v/v) as the mobile phase at the flow rate of 0.5 mL min(-1). The detection wavelength for CSS, allantoin and VB(6) was 195 nm, 215 nm and 291 nm, respectively. The method showed good linearity for CSS, allantoin and VB(6), with correlation coefficients greater than 0.9996, in the range of 203.96-815.84 mg L(-1), 371.16-1488.64 mg L(-1), and 23.32-93.28 mg L(-1), respectively. The instrumental and method precisions were adequate with all relative standard deviations lower than 2.0%. The accuracy of this method, measured by the recovery of three compounds from spiked placebo solutions, was from 99.01% to 101.92%. The three components, CSS, allantoin and VB(6) were well separated from other ingredients and degradation products. This method is fast, simple, and can be used for direct and simultaneous determination of CSS, allantoin and VB(6) in the pharmaceutical preparation.
Jin
Pengfei
P
Department of Pharmaceutical Science, Beijing Hospital, No. 1 Dahua Road, Dongcheng District, Beijing 100730, China. j790101@sohu.com
Ma
Jie
J
Wu
Xuejun
X
Zou
Ding
D
Sun
Chunhua
C
Hu
Xin
X
D000481:Allantoin / Q000032:analysis*; D002809:Chondroitin Sulfates / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D009883:Ophthalmic Solutions; D011736:Pyridoxine / Q000032:analysis*; D015203:Reproducibility of Results; D014803:Vitamin B Complex / Q000032:analysis
D009883:Ophthalmic Solutions; D014803:Vitamin B Complex; D000481:Allantoin; D002809:Chondroitin Sulfates; D011736:Pyridoxine