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Analytical method validation of oxiracetam using HPLC
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2010, v.23 no.6, pp.587-594
https://doi.org/10.5806/AST.2010.23.6.587
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(2010). Analytical method validation of oxiracetam using HPLC. Analytical Science and Technology, 23(6), 587-594, https://doi.org/10.5806/AST.2010.23.6.587
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Abstract
완제품의 주성분인 옥시라세탐이 함유된 의약품의 시험법실시 계획서에 따른 시험이 적절히 진행되었는지 시험법의 검증여부를 하고 본 protocol이 완제품 중 옥시라세탐의 정량분석을 위한 HPLC 분석법의 타당성을 검증하기 위한 문서화된 절차를 제공하는 것을 목적으로 한다. 본 실험에서는 옥시라세탐 함량시험에 사용된 분석법에 대하여 시스템 적합성, 정밀성, 직선성, 범위, 정확도, 특이성, 정량한계,검출한계에 대하여 확인하였다. 실험결과 시스템적합성에서 정밀도(RSD%) 0.127%이하, 이론단수 15081,tailing factor 0.49, 그리고 분리능 32.41을 나타내었고, 정밀도실험에서는 RSD% 0.359% 이하의 결과를보였다. 그리고 직선성 실험에서는 상관계수(R2)가 1을 나타내었고, 정확도 실험에서는 recovery test로서최소 98.4%, 최대 99.6%로 기준을 만족하였다. 검출한계는 0.1 mg/L이였으며, 정량한계는 0.5 mg/L이었다. 그리고 특이성 실험에 있어서도 기준을 만족하는 결과를 나타내어 옥시라세탐을 주성분으로 하는 완제의약품 시험법은 적합한 시험법임이 검증되었다.
- keywords
- analytical method validation, HPLC, oxiracetam, system suitability
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