Author
J. Gómez Maldonado
Bio: J. Gómez Maldonado is an academic researcher. The author has contributed to research in topics: Microparticle Enzyme Immunoassay. The author has an hindex of 1, co-authored 1 publications receiving 4 citations.
Topics: Microparticle Enzyme Immunoassay
Papers
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TL;DR: Investigation of whether hemoglobin, hematocrit, and tome from kidney transplantation influence results obtained using the immune-enzymatic technique renders enzyme immunoassay a good alternative for the measurement of sirolimus levels in whole blood finding its correlation with chromatography is acceptable.
4 citations
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TL;DR: The rapid and sensitive developedRP-HPLC method can be used for the routine analysis of sirolimus such as dissolution and stability assays of pre- and post-marketed dosage forms.
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.
21 citations
TL;DR: The Innofluor® FPIA is a valid alternative with an analogous performance to the MEIA for the therapeutic monitoring of sirolimus and no significant effect was found for siro Limus clearance or the blood hematocrit on the relationship between the results produced by both immunoassays and HPLC.
Abstract: Background. Although high-performance liquid chromatography (HPLC) is the method of choice for blood sirolimus determination, the microparticle enzyme immunoassay (MEIA) run on the IMx® analyser is widely used in therapeutic monitoring of this immunosuppressant agent. The aim of our study was to evaluate the possible determination of sirolimus using the fluorescence polarization immunoassay (FPIA) commercialized for everolimus quantification.Methods. Sirolimus concentrations were determined in whole-blood samples from liver and kidney transplant recipients using the Innofluor® Certican® FPIA (Seradyn Inc.) run on a TDx® analyser (Abbott Laboratories), Sirolimus MEIA run on an IMx® analyser (Abbott Laboratories), and HPLC (UV detection) methods.Results. The Innofluor® FPIA has a similar cross-reactivity with everolimus and sirolimus, and the within- and between-run coefficients of variation obtained for sirolimus determination were 2.7%–13.3%. In analysing different blood samples from liver and kidney tran...
9 citations
TL;DR: It is concluded that, despite the analytical bias, this immunoassay offers a viable alternative to the use of HPLC and would be an assay suitable for implementing at local centers.
Abstract: Measurement of sirolimus as a guide to therapy is widely accepted. Since the commercial introduction of the drug, the only method available to measure blood concentrations has been high-performance liquid chromatography (HPLC). Only a limited number of centers have the facilities to perform this technique and, as a result, the measurement of the drug has been performed in central laboratories, often some distance from the clinical centers. This article describes a single-center assessment of a new immunoassay to measure sirolimus, including a comparison between immunoassay results and a chromatographic technique. Calibration accuracy was good, reproducibility at 11 ng/mL was better than 6%, and sensitivity was better than 2 ng/mL; all these parameters are appropriate for routine clinical use. There was a mean positive bias of almost 20% for the measurement of sirolimus in clinical samples from kidney transplant patients receiving the drug, compared with HPLC. This bias was most likely due to cross-reactivity with metabolites of the drug and was of the order noted when an earlier configuration of this immunoassay was used in clinical practice. We conclude that, despite the analytical bias, this immunoassay offers a viable alternative to the use of HPLC and would be an assay suitable for implementing at local centers.
6 citations