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Rapid Resolution Liquid Chromatography Method Development and Validation for Detection of Anastrozole in Human Serum
Author(s) -
Abubakar Murtala,
Gan Siew
Publication year - 2015
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.29.1_supplement.779.5
Subject(s) - chromatography , anastrozole , resolution (logic) , human plasma , chemistry , medicine , computer science , artificial intelligence , cancer , breast cancer , aromatase
Globally, breast cancer is a common cause of cancer mortality among women. Current treatment guidelines for estrogen‐receptor positive breast cancer recommend the use of anastrozole as one of the alternatives to tamoxifen. To date, no rapid resolution liquid chromatography (RRLC) method for the detection of anastrozole in human serum has been developed. A simple, accurate, highly sensitive and reproducible RRLC method was developed for quantitative measurement of anastrozole in human serum with a mobile phase consisting of a mixture of acetonitrile and ammonium acetate (45:55) with 0.05% triethylamine added at a pH of 4.0 running at 0.4 mL/min. Separation was achieved using a C‐18 column (3.5 µm, 150 x 4.6 mm) maintained at 30 o C and the detection was monitored at 210 nm. The retention time of the drug was 9.3 min. The system suitability parameters such as capacity factor, tailing factor, resolution, and plate count as well as validation parameters such as linearity, precision and accuracy complied with the FDA guideline. The method showed a good linearity (R 2 = 0.9996) at a concentration range of 50 to 1600 ng/mL. The intra‐ and inter‐day precisions were 85.98% to 104.03% while limit of detection and limit of quantification were 10 and 50 ng/mL respectively. The proposed method is suitable for quantitative determination of anastrozole in human serum.