TY - JOUR
T1 - A simple, precise, and sensitive HPLC method for quantification of letrozole in rat plasma
T2 - development, validation, and preclinical pharmacokinetics
AU - Hegde, Aswathi R.
AU - Padya, Bharat Singh
AU - Soman, Soji
AU - Mutalik, Srinivas
N1 - Funding Information:
The authors are thankful to Gland Pharma Ltd., Malur, Karnataka, India for providing gift sample of letrozole. The authors express their sincere thanks to (i) All India Council for Technical Education (AICTE), Government of India, New Delhi (for National Doctoral Fellowship to Bharath S Padya) and (ii) Department of Science and Technology, Government of India, New Delhi (for DST-INSPIRE Junior Research Fellowship to Soji Soman). The authors are grateful to Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, for providing the necessary facilities.
Funding Information:
The authors are thankful to Gland Pharma Ltd., Malur, Karnataka, India for providing gift sample of letrozole. The authors express their sincere thanks to (i) All India Council for Technical Education (AICTE), Government of India, New Delhi (for National Doctoral Fellowship to Bharath S Padya) and (ii) Department of Science and Technology, Government of India, New Delhi (for DST-INSPIRE Junior Research Fellowship to Soji Soman). The authors are grateful to Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, for providing the necessary facilities.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - A simple bioanalytical liquid chromatographic method was developed and validated to quantify letrozole (LTZ) in rat plasma. Protein precipitation using acidified chilled acetonitrile (containing 0.1% orthophosphoric acid) was used to extract LTZ from the plasma. Chromatographic separation was carried out on Kinetex C18 reverse phase (RP) column (250 mm × 4.6 mm i.d., 5 μm) using a mixture of 20 mM acetate buffer (pH 5.5) and acetonitirile (60:40 %v/v) eluting at 1.0 mL/min flow rate with the method responses measured at 240 nm. The optimized method was selective and established good linearity with recovery ranging between 91.16 and 99.44%. The validation experiments revealed that the method showed acceptable precision (2.61–7.48%) and accuracy (97.44–102.70%) and was found to be stable. The sensitivity of the method was demonstrated by the lowest concentration (LLOQ) detected at 75 ng/mL. Using the developed method, single-dose oral pharmacokinetics in Sprague-Dawley rats was carried out to successfully confirm the applicability of the method for the quantification of LTZ in biological matrix.
AB - A simple bioanalytical liquid chromatographic method was developed and validated to quantify letrozole (LTZ) in rat plasma. Protein precipitation using acidified chilled acetonitrile (containing 0.1% orthophosphoric acid) was used to extract LTZ from the plasma. Chromatographic separation was carried out on Kinetex C18 reverse phase (RP) column (250 mm × 4.6 mm i.d., 5 μm) using a mixture of 20 mM acetate buffer (pH 5.5) and acetonitirile (60:40 %v/v) eluting at 1.0 mL/min flow rate with the method responses measured at 240 nm. The optimized method was selective and established good linearity with recovery ranging between 91.16 and 99.44%. The validation experiments revealed that the method showed acceptable precision (2.61–7.48%) and accuracy (97.44–102.70%) and was found to be stable. The sensitivity of the method was demonstrated by the lowest concentration (LLOQ) detected at 75 ng/mL. Using the developed method, single-dose oral pharmacokinetics in Sprague-Dawley rats was carried out to successfully confirm the applicability of the method for the quantification of LTZ in biological matrix.
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U2 - 10.1186/s40543-021-00276-4
DO - 10.1186/s40543-021-00276-4
M3 - Article
AN - SCOPUS:85107565394
SN - 2093-3134
VL - 12
JO - Journal of Analytical Science and Technology
JF - Journal of Analytical Science and Technology
IS - 1
M1 - 25
ER -