scholarly journals Bio analytical method development and validation for Ezetimibe and Pitavastain and its applications to pharmacokinetic studies in Rabbit plasma by using LCMS/MS

2020 ◽  
Vol 11 (4) ◽  
pp. 7854-7862
Author(s):  
Potturi Ramadevi ◽  
Kantipudi Rambabu
Keyword(s):  
Method Development ◽  
Extraction Process ◽  
Pharmacokinetic Studies ◽  
Rabbit Plasma ◽  
Highly Sensitive ◽  
The Us ◽  
Positive Mode ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Preparation Techniques

For the gradation of Ezetimibe and Pitavastain in rabbit plasma, a highly sensitive and simple LC-MS/MS assay was developed and witnessed. The chromatographic conditions are isocratic with a waters symmetry C18 (150 x 4.6 mm, 3.5) column in isocratic mode. The detection was carried out using a mobile phase of 0.1 percent formic acid and 60:40 acetonitrile, and the detection was carried out using MS in a positive mode of electrospray ionisation. The valid approach was checked with a linear range of 10-200 ng/ml Ezetimibe and 2-40 ng/ml Pitavastain. The intraday and interday precision values were found to be within reasonable limits. The liquid extraction process is used to remove these drugs from rabbit plasma. And these drugs have been shown to be stable in freeze-thaw, autosampler, and benchtop tests in the future. The fluid chromatography coupled mass spectrometry strategy was approved by the US Food and Drug Administration for quantification of Ezetimibe and Pitavastain in rabbit plasma using D4–ezetimibe and D4–pitavastain as within norms using LC-MS consolidated with quadrupole spectrometer by electro shower ionisation process. The aim of this study is to evaluate the applicability of this approach to ezetimibe and pitavastain at different evaluation levels while taking into account various factors such as instrument stability, precision, and accuracy, sample preparation techniques, instrument calibration, recovery, and matrix effect by using Ezetimibe and Pitavastain, as well as their internal guidelines.

Bioanalytical Method Development of Atenolol Enantiomers: Stereoselective Behavior in Rabbit Plasma by RP-UFLC Method

2019 ◽  
Vol 16 ◽  
Author(s):  
Charan Raju C ◽  
B M Gurupadayya ◽  
Prachi Raikar
Keyword(s):  
Method Development ◽  
Pharmacokinetic Studies ◽  
Pharmacokinetic Data ◽  
Rabbit Plasma ◽  
Bioanalytical Method ◽  
Sodium Hydrogen Phosphate ◽  
Method Development And Validation ◽  
Rate Of Recovery ◽  
Fast Liquid Chromatography ◽  
Development And Validation

Objective: The objective of the method was to develop a new, simple and reliable enantioselective Reverse Phase- Ultra Fast Liquid Chromatography (RP-UFLC) method for the separation of Atenolol enantiomers. Comprehensive study was performed by extending the work to pharmacokinetic studies using rabbit plasma. Background: Many methods were reported for enantioseparation of Atenolol enantiomers but, no attempts were made for chiral separation of Atenolol using rabbit plasma. Moreover, pharmacokinetic data to prove the efficiency of particular enantiomers in rabbit plasma was not studied. Method: In the present examination, the binary RP-UFLC technique was developed on Phenomenex® Lux cellulose i5 segment (150×4.6 mm, 5µ) using di-sodium hydrogen phosphate buffer (pH 6.8): acetonitrile (35:65 v/v) as the mobile phase. Results: The elution of Atenolol was observed at 225 nm with a stream rate of 1 mL.min-1. The described technique offered a linear relationship with a regression coefficient of r2= 0.997 and 0.996 for (R) and (S)-enantiomer respectively between the concentration range of 2-10 ng.mL-1. Atenolol enantiomers were detected at a retention time (tR) of 2.7 min and 3.10 min R and S-enantiomer respectively. The rate of recovery of both Atenolol enantiomers was observed to be (R) 98.18% and (S) 100.45% individually. USFDA guidelines May 2018, were systematically followed for bioanalytical method development and validation. Conclusion: The developed technique was applied for the separation of Atenolol enantiomers and for the pharmacokinetic determination of Atenolol enantiomers in rabbit plasma.

scholarly journals BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AVELUMAB, AXITINIB AND ITS APPLICATION TO PHARMACOKINETIC STUDIES IN RABBIT PLASMA BY USING LCMS/MS

2021 ◽  
pp. 198-204
Author(s):  
SYED RAFI ◽  
KANTIPUDI RAMBABU
Keyword(s):  
Mobile Phase ◽  
Method Development ◽  
Internal Standard ◽  
Pharmacokinetic Studies ◽  
Rabbit Plasma ◽  
System Suitability ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Stability Results ◽  
Good Agreement

Objective: An easy, quick, precise, active and reproducible LC-MS/MS technique was developed for the bioanalytical method of Avelumab and Axitinib using Cytarabine as an internal standard. Methods: This article summarizes the recent progress on bioanalytical LC-MS/MS methods using waters x-bridge phenyl column (150x4.6 mm, 3.5µ) column and organic mobile phase of 0.1% Tri fluoro acetic acid and Acetonitrile in 50:50 ratio. Results: The calibration curve was linear in the range of 2-40 ng/ml for avelumab and 0.5-10 ng/ml axitnib. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. Simple and efficient method was developed and utilized in pharmacokinetic studies to see the investigated analyte in body fluids. Conclusion: The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with USFDA guidelines and applied effectively for the investigation of pharmacokinetic studies in rabbit.

Bioanalytical Method Development and Validation for the Determination of Vasopressin Receptor Antagonist Conivaptan in Mouse Plasma at NanoLevel and its Pharmacokinetic Application

2019 ◽  
Vol 15 (5) ◽  
pp. 591-598 ◽  
Author(s):  
Haitham Alrabiah ◽  
Ahmed Bakheit ◽  
Sabray Attia ◽  
Gamal A.E. Mostafa
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Vasopressin Receptor ◽  
Mouse Plasma ◽  
Precipitation Procedure ◽  
Validation Parameters ◽  
The Us ◽  
Method Development And Validation ◽  
Development And Validation

Background: Conivaptan inhibits two of vasopressin receptor (vasopressin receptor V1a and V2). Conivaptan is used for the treatment of hyponatremia, and in some instances, for the treatment of the heart failure. Methods: The present study aimed to develop a simple, sensitive, and accurate HPLC with ultraviolet detection for the assay of conivaptan (CON) in mouse plasma using bisoprolol as internal standard (IS). A precipitation procedure was used to extract CON and the IS from the mouse plasma. CON was chromatographically separated using a C18 analytical column at 25°C. The separation was carried out using a mixture of phosphate buffer (50 mM): acetonitrile (60: 40, v/v, pH 4.5) with a flow rate of 1.0 mL/min and detection was performed at 240 nm. Results: The assay was validated according to the US Food and Drug (FDA) guidelines. The method demonstrated linearity over a concentration range of 150 - 2000 ng/mL (correlation coefficient: r 2 = 0.9985). The mean recovery of CON from the mouse plasma was 101.13%. All validation parameters for CON were within the acceptable range. Conclusion: The investigated method has been shown to be suitable for estimating the CON in plasma samples, and this method is sensitive and highly selective, allowing the estimation of its concentrations up to the nano-scale. The suggested method was successfully used in a pharmacokinetic study of CON in mouse plasma.

scholarly journals VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB IN BULK AND FORMULATION

2020 ◽  
pp. 63-67
Author(s):  
SMITA KUMBHAR ◽  
VINOD MATOLE ◽  
YOGESH THORAT ◽  
ANITA SHEGAONKAR ◽  
AVINASH HOSMANI
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Uv Spectrum ◽  
Colored Complex ◽  
Pharmaceutical Dosage Forms ◽  
Highly Sensitive ◽  
Method Development And Validation ◽  
Development And Validation

Objective: A new, simple, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the determination of Imatinib in pharmaceutical formulations with alizarin. Methods: The method is based on formation of yellow-colored complex. The UV spectrum of Imatinib in methanol showed λ max at 431 nm. Beer’s law is valid in the concentration range of 10-70 μg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-70 μg/ml with regression equation y =0.013x-0.017 and regression correlation coefficient r2= 0.997. Moreover, the method was found to be highly sensitive with LOD (4.3μg/ml) and LOQ (13.07μg/ml). Conclusion: Based on results the proposed method can be successfully applied for the assay of Imatinib in various pharmaceutical dosage forms.

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