OPEN-ACCESS PEER-REVIEWED

1Ravikumar Vejendla, 2Sri Hari Galla, 3Sivanna Chithanna

1Department of Pharmaceutical Analysis, St.Mary’s Pharmacy College, Deshmukhi, Hyderabad.

2Medicinal Chemistry Department, University of Louisville, 505 South Hancock Street, Louisville, KY 40202, USA

3Medicinal Chemistry Department, University of Louisville, 505 South Hancock Street, Louisville, KY 40202, USA

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Abstract

Background: authors want to define the procedure for LC-ESI-MS/MS, a technique utilized in bio-analytical research to establish a simple technique for determining the level of Niraparib in K3EDTA plasma from human beings, is a combination of liquid chromatography, electro spray ionization and mass spectro-photometry. Niraparib in plasma samples has been measured using a sensitive and efficient technique.

Materials and methods: Chromatographic elution was done by using 10mM Ammonium acetate pH-5.0 (A) : acetonitrile (B) in the ratio of 10:90v/v as mobile phase having flow rate of 1.0 milli-liter per minute, Gemini 5µ C18150 x 4.6 mm column. 70% division of flow was used for chromatographic separation of Niraparib with an ISTD as Niraparib-D5.

Results: System Suitability: Area ratio < 2.06%, ISTD RT, and analyte RT% CV ≤ 2.06%. System performance: internal standard residual ≤ 1.07, analyte carryover < 6045, signal to noise ratio ≥ 270.0. Over LOQ & LOQQC 0.0005 µg/ml, LQC 0.00134 µg/mL, MQC 0.02 µg/mL and HQC 0.04 µg/mL, this approach is verified, ULOQ 0.05 µg/mL, and linear concentration range of 0.0005 µg/mL to 0.05 µg/mL with a correlation coefficient (r2) of ≥ 0.9997. Stability investigations indicated that the developed conduct was suitable for use with K3EDTA plasma samples when it was validated.

Summary: The LC-MS/MS technique that was created to quantify the amount of Niraparib in the biological matrix worked well for routine blood sample analysis from patients for pharmacokinetics research and medication monitoring.

Keywords: Niraparib, Niraparib-D5, LC-ESI-MS/MS, LQC, MQC, HQC, ULOQ, Validation, Stability

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