Bio-analytical method development and validation for simultaneous determination of bictegravir, emtricitabine, and tenofovir alafenamide fumarate in human plasma by LC-MS/MS
By: Attaluri, Tanuja
.
Contributor(s): Ganapaty, Seru.
Publisher: Bangalore Association of Pharmaceutical Teachers of India (APTI) 2022Edition: Vol.56(4), Oct-Dec.Description: 1190-1205p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical education and researchSummary: Aim: The current method was developed as a novel and reliable quantitative liquid
chromatography-mass (tandem) spectrometry (LC-MS/MS) method for the estimation of
analytes like Bictegravir (BIC) Tenofovir Alafenamide Fumarate (TNF), and Emtricitabine
(EMT) in plasma of human simultaneously. Materials: Naproxen (NPX) is used as the
internal standard for the current study. The ‘Precipitation Extraction technique’ is used
for the present study. The Zorbax XDB C18 analytical column (2.1 X 50 and particle size
of 5μm) is used for the chromatographic separation with isocratic natured mobile phase,
which consists of Acetonitrile: Formic acid (0.1%) in water (70:30, v/v), at a flow rate
of 0.15 mL/minute. Methods: The parent→production conversions were observed at m/z
450.1 → 289.1 (BIC), m/z 248.3 → 130.03 (EMT), m/z 477.3 → 270.04 (TNF), and
m/z 231.12 → 184.82 (NPX) on a triple quadrupole mass spectrometer, operating in the
multiple reaction monitoring (MRM) positive ion mode. The three compounds were found
to possess primary groups hence positive manner was selected for the LC-MS/MS study.
Results: The subject method validation was performed for the concentration of range
2-500 ng for Bictegravir (BIC), Emtricitabine (EMT), and Tenofovir Alafenamide Fumarate
(TNF). The obtained mean recoveries for the three-drug moieties from samples of spiked
plasma were found reproducible. Conclusion: Hence, based on the above, the method
was proved to be rugged and rapid, with a least total run time of 3.0 min. The current
method was successfully validated according to the FDA, EMA, and ICH guidelines, and
the stability studies were evaluated accordingly.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
|
School of Pharmacy Archieval Section | Not for loan | 2023-0126 |
Aim: The current method was developed as a novel and reliable quantitative liquid
chromatography-mass (tandem) spectrometry (LC-MS/MS) method for the estimation of
analytes like Bictegravir (BIC) Tenofovir Alafenamide Fumarate (TNF), and Emtricitabine
(EMT) in plasma of human simultaneously. Materials: Naproxen (NPX) is used as the
internal standard for the current study. The ‘Precipitation Extraction technique’ is used
for the present study. The Zorbax XDB C18 analytical column (2.1 X 50 and particle size
of 5μm) is used for the chromatographic separation with isocratic natured mobile phase,
which consists of Acetonitrile: Formic acid (0.1%) in water (70:30, v/v), at a flow rate
of 0.15 mL/minute. Methods: The parent→production conversions were observed at m/z
450.1 → 289.1 (BIC), m/z 248.3 → 130.03 (EMT), m/z 477.3 → 270.04 (TNF), and
m/z 231.12 → 184.82 (NPX) on a triple quadrupole mass spectrometer, operating in the
multiple reaction monitoring (MRM) positive ion mode. The three compounds were found
to possess primary groups hence positive manner was selected for the LC-MS/MS study.
Results: The subject method validation was performed for the concentration of range
2-500 ng for Bictegravir (BIC), Emtricitabine (EMT), and Tenofovir Alafenamide Fumarate
(TNF). The obtained mean recoveries for the three-drug moieties from samples of spiked
plasma were found reproducible. Conclusion: Hence, based on the above, the method
was proved to be rugged and rapid, with a least total run time of 3.0 min. The current
method was successfully validated according to the FDA, EMA, and ICH guidelines, and
the stability studies were evaluated accordingly.
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