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Home / Chinese Journal of Pharmaceutical Analysis, Volume 32, Number 6

RP-HPLC determination of methylpredisolone sodium succinate injection and its related substances

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Objective: To establish an RP-HPLC method for determination of methylpredisolone succinate injection and its related substunces. Method: Zorbax-XDB-C18 column(100 mm×4.6 mm,5 μm) was used.Mobile phase was 0.66% tetrabutylammonium hydroxide solution(pH was adjusted to 6.5 by phosphoric acid)-acetonitrile(3:2),the flow rate was 1.0 mL·min-1and the detection wavelength was 254 nm. Results: Calibration curve of methylpredisolone succinate was linear range of 100-900 μg·mL-1(r=1.00000),and the average recoveries of its high,middle and low concentrations were 100.7%,100.5% and 100.7%,respectively.Calibration curve of methylpredisolone was linear range of 10-50 μg·mL-1(r=0.99995),and the average recoveries of its high,middle and low concentrations were 100.5%,100.6% and 100.3%,respectively. Conclusions: The RP-HPLC method is employed instead of the former NP-HPLC.This method is accurate and reliable,so it can be used for quality control of methylpredisolone sodium succinate injection.

PLEASE NOTE: The full text of this publication is in Chinese.

Keywords: RP-HPLC; assay; methylpredisolone sodium succinate; methylprednisolone; relative substance

Document Type: Research Article

Publication date: 01 January 2012

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  • Journal of Pharmaceutical Analysis is a professional journal administrated by China Association for Science and Technology, sponsored by Chinese Pharmaceutical Association, held by National Institutes for Food and Drug Control, edited and published by the Editorial Board of Journal of Pharmaceutical Analysis, and publicly distributed at home and abroad. It is one of the first group of journals that created by academic leaders in the field of drug control. It originated from Drug Control Communication which magazine was founded in 1951 and later been renamed in 1981. In 2005, it was changed from bi-monthly journal to monthly journal. Journal of Pharmaceutical Analysis is among core journals in nature sciences and even other Chinese core journals, whose main columns are research reports, communications, review, forum, information and etc. It mainly reports the latest research results, explore new theories, introduce new development, spread new techniques, and promote new methods of pharmaceutical analysis. Its contents include peer-reviewed research reports, research presentation and summary reviews on all aspects of pharmaceutical analysis including drug development, pharmaceutical manufacturing, clinical research, drug safety, quality assessment, and market surveillance. Main authors and target reader are professional and technical personnel engaged in research, application as well as higher education in pharmaceutical analysis.
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