Quantification of Tamoxifen Polymeric Nanoparticles in female rodent breast tissue by UPLC/ESI-Q-TOF MS/MS

    Published on:August 2016
    Journal of Young Pharmacists, 2016; 8(4):415-423
    Original Article | doi:10.5530/jyp.2016.4.18
    Authors:

    Md Aftab Alam1, Niyaz Ahmad2*, Rizwan Ahmad3, Sushama Talegaonkar4, Farhan Jalees Ahmad4, Zeenat Iqbal4, Amulya K. Panda5

    1Department of Pharmaceutics, School of Medical and Allied Sciences, Galgotias University, Gautam Budh Nagar, Greater Noida-201310, INDIA.

    2Department of Pharmaceutics, College of Clinical Pharmacy, Dammam University, Dammam- 31441, KINGDOM OF SAUDI ARABIA.

    3Department of Natural Products and Alternative Medicine, College of Clinical Pharmacy, Dammam University, Dammam-31441, KINGDOM OF SAUDI ARABIA.

    4Department of Pharmaceutics, Nanomedicine Lab, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi-110062, INDIA.

    5Product Development Cell-II, National Institute of Immunology, New-Delhi-110067, INDIA.

    Abstract:

    Objective: The present work aims to develop and validate stability indicating a novel liquid chromatography method with applicability i.e. to study the pharmacokinetics factor as well as estimate Tamoxifen (TMX) in bio-analytes, using Ultra High Pressure Liquid Chromatography/ Mass Spectrometry (UPLC-ESI-Q-TOF-MS/MS) in plasma. Methods: A bioanalytical method based on UPLC-ESI-Q-TOF-MS/MS has been developed and validated for the quantitative determination of TMX in female mice plasma using Clomiphine as an Internal Standard (IS). After Liquid-liquid extraction (LLE), analyte and IS, chromatographic separation was achieved on ACQUITY UPLC BEH C18 Waters column with dimensions; 100 mm × 2.1 mm; 1.7 μm, isocratic mobile phase (Acetonitrile:2 mM ammonium formate: 90:10; v/v), and a flow rate of 0.25 mL min-1. Results: The transitions occurred at m/z 372.1→178.1 and m/z 407.1 → 100.1 for TMX and IS, respectively. Liquidliquid extraction technique (LLE) using ethyl acetate was applied in order to optimize the recovery of analytes in mice plasma. The run and retention time of TMX were 6.0 and 2.63 minutes, respectively while the linear dynamic range established was 1.002-4001.07 ng/ml (r2>0.998 ± 0.0003). Intra-assay and inter-assay accuracy (% RSD) was found in the range; 2.43- 3.49. Conclusion: The proposed LC–MS/MS assay method is simple, rapid and sensitive for the determination of TMX in mice plasma for pharmacokinetic studies. Analytes were stable under various conditions i.e. autosampler, freeze–thaw, at room temperature, and under deep freeze conditions.

    Key words Tamoxifen, Breast Cancer, UPLC/ESI-Q-TOF-MS/MS method Validation, Polymeric nanoparticles, Pharmacokinetics.

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