근적외부스펙트럼 측정법을 이용한 록소프로펜의 정량화 및 밸리데이션

국문 초록 (Abstract)

본 논문에서는 록소프로펜 제제의 분석 시간을 단축하고 제품 출하 속도를 향상시키기 위하여 근적외부 (NIR) 스펙트럼 측정법을 이용하여 기존에 사용하던 HPLC 방법과 상호 비교해 보고자 하였다. 제제학적으로 사용되 는 다른 첨가제들과 함께 록소프로펜 혼합시료를 제조하고, NIR 분광광도계와 HPLC로 록소프로펜을 정량하고 평가 하였다. 두 시험법의 밸리데이션 항목으로 특이성, 정확성 및 정밀성을 실시하였다. NIR 측정법이 검증되었고, 제약산 업 분야의 제조공정 중 품질관리를 위한 적합한 결과를 얻었다. 결론적으로 록소프로펜을 분석하는데 있어서 NIR 측 정법을 사용하면 기존의 HPLC 정량법을 NIR의 결과로 대치할 수 있을 것이다.

다국어 초록 (Multilingual Abstract)

In this study, we used NIR spectrum method instead of conventional HPLC method to shorten the analysis and manufacturing time of the loxoprofen products. Loxoprofen mixtures with other pharmaceutical additives were prepared and evaluated by the NIR spectrometer and the HPLC system. Validation of both methods was performed for specificity, accuracy and precision. NIR spectrometer method was validated and revealed proper results for the in-process quality control in the pharmaceutical field. In conclusion, NIR spectrometry can be replaced by HPLC method.

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