Tabriz University of Medical Sciences Advanced Pharmaceutical Bulletin 2228-5881 2 2 2012 12 30 Development and Validation of an HPLC Method for the Analysis of Sirolimus in Drug Products 135 139 10.5681/apb.2012.021 EN Ziba Islambulchilar Saeed Ghanbarzadeh Shahram Emami Hadi Valizadeh Parvin Zakeri-Milani Journal Article 10.5681/apb.2012.021 2012 02 10 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.