DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR THE ANALYSIS OF SIROLIMUS IN DRUG PRODUCTS

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ISLAMBULCHILAR ZIBA; GHANBARZADEH SAEED; EMAMI SHAHRAM; VALIZADEH HADI; ZAKERI MILANI PARVIN

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Journal Paper

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Journal: Advanced Pharmaceutical Bulletin Year:2012 | Volume:2 | Issue:2 Page(s): 135-139

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Title

DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR THE ANALYSIS OF SIROLIMUS IN DRUG PRODUCTS

Author(s)

Keywords

SIROLIMUS

HPLC

METHOD DEVELOPMENT

VALIDATION

ULTRAVIOLET

CHROMATOGRAPHY

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 125-2000 ng/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.

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APA: Copy

ISLAMBULCHILAR, ZIBA, GHANBARZADEH, SAEED, EMAMI, SHAHRAM, VALIZADEH, HADI, & ZAKERI MILANI, PARVIN. (2012). DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR THE ANALYSIS OF SIROLIMUS IN DRUG PRODUCTS. ADVANCED PHARMACEUTICAL BULLETIN, 2(2), 135-139. SID. https://sid.ir/paper/331667/en

Vancouver: Copy

ISLAMBULCHILAR ZIBA, GHANBARZADEH SAEED, EMAMI SHAHRAM, VALIZADEH HADI, ZAKERI MILANI PARVIN. DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR THE ANALYSIS OF SIROLIMUS IN DRUG PRODUCTS. ADVANCED PHARMACEUTICAL BULLETIN[Internet]. 2012;2(2):135-139. Available from: https://sid.ir/paper/331667/en

IEEE: Copy

ZIBA ISLAMBULCHILAR, SAEED GHANBARZADEH, SHAHRAM EMAMI, HADI VALIZADEH, and PARVIN ZAKERI MILANI, “DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR THE ANALYSIS OF SIROLIMUS IN DRUG PRODUCTS,” ADVANCED PHARMACEUTICAL BULLETIN, vol. 2, no. 2, pp. 135–139, 2012, [Online]. Available: https://sid.ir/paper/331667/en

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