A size-exclusion HPLC method for the determination of sodium chondroitin sulfate in pharmaceutical preparations.
A size-exclusion HPLC method for the determination of sodium chondroitin sulfate (SCS) in pharmaceutical preparations has been developed and validated. The most important feature of this method compared with the previously reported assay methods was improved economical and determinative applications through direct analysis of SCS from pharmaceuticals. The linearity, precision, specificity, and accuracy of the method were established and validated. The intra- and inter-day precision was satisfactory with relative standard deviation lower than 1.0%. The recovery of SCS from multi-components pharmaceutical preparations were from 93.38 to 100.46%. Comparing our HPLC assay results with classical spectrophotometric methods, the developed method was considerably easy, simple and reproducible. As a result, the present method was supposed to be successfully applied to the assay of SCS for the routine quality control in pharmaceutical preparations.
Choi
Don Woong
DW
Department of Drug Evaluation, Korea Food and Drug Administration, 5 Nokbun-Dong, Eunpyung-Gu, Seoul 122-704, Republic of Korea. cdwkje@hanmail.net
Kim
Mi Jung
MJ
Kim
Hee Sung
HS
Chang
Soo Hyun
SH
Jung
Gi Sook
GS
Shin
Kyung Yong
KY
Chang
Seung Yeup
SY
D002809:Chondroitin Sulfates / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004364:Pharmaceutical Preparations / Q000032:analysis*
D004364:Pharmaceutical Preparations; D002809:Chondroitin Sulfates