VALIDATION OF UV-SPECTROMETRY ASSAY METHOD FOR DISSOLUTION PROFILE TEST FOR MOXIFLOXACINE TABLETS

Разработка и регистрация лекарственных средств

Yu. E. Boldina¹  A. A. Lvova²  I. E. Shohin²  Yu. V. Medvedev²  T. N. Komarov²  L. A. Menshikova³ 

[1] FSBIS SCBMT FMBA;Center of Pharmaceutical Analytics Ltd.;I.M. Sechenov First Moscow State Medical University;

关键词: moxifloxacine;    validation;    uv-spectrophotometry;    dissolution profile test;   

DOI  :  

来源: DOAJ

【 摘 要 】

Validation of UV-spectrometry assay method for dissolution profile test for levofloxacine tablets was carried out. The evaluated validation characteristics were: specificity, linearity, accuracy, precision, and analytical range. It was shown than main validation characteristics meet the Russian State Pharmacopoeia XIII requirements.

【 授权许可】

Unknown