Repository of Research and Investigative Information

Repository of Research and Investigative Information

دانشگاه علوم پزشکی و خدمات بهداشتی درمانی زنجان

Development and validation of an HPLC method for the analysis of sirolimus in drug products

(2012) Development and validation of an HPLC method for the analysis of sirolimus in drug products. Advanced Pharmaceutical Bulletin. pp. 135-139.

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Official URL: https://www.scopus.com/record/display.uri?eid=2-s2...

Abstract

Purpose: The aim of this study was to develop a simple, rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method for quantification of sirolimus (SRL) in pharmaceutical dosage forms. Methods: The chromatographic system employs isocratic elution using a Knauer- C18, 5 mm, 4.6 × 150 mm. Mobile phase consisting of acetonitril and ammonium acetate buffer set at flow rate 1.5 ml/min. The analyte was detected and quantified at 278nm using ultraviolet detector. The method was validated as per ICH guidelines. Results: The standard curve was found to have a linear relationship (r2 > 0.99) over the analytical range of 125-2000ng/ml. For all quality control (QC) standards in intraday and interday assay, accuracy and precision range were -0.96 to 6.30 and 0.86 to 13.74 respectively, demonstrating the precision and accuracy over the analytical range. Samples were stable during preparation and analysis procedure. Conclusion: Therefore the rapid and sensitive developed method can be used for the routine analysis of sirolimus such as dissolution and stability assays of pre- and post-marketed dosage forms. © 2012 by Tabriz University of Medical Sciences.

Item Type: Article
Keywords: Sirolimus | Calcineurin | calcineurin inhibitor
Page Range: pp. 135-139
Journal or Publication Title: Advanced Pharmaceutical Bulletin
Abstract and Indexing: Pubmed, Scopus
Volume: 2
Number: 2
Publisher: scopus, pubmed
Depositing User: خانم مریم زرقانی
URI: http://repository.zums.ac.ir/id/eprint/1619

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