Development and validation of a HPLC method for simultaneous quantitation of gatifloxacin, sparfloxacin and moxifloxacin using levofloxacin as internal standard in human plasma: application to a clinical pharmacokinetic study

2008 ◽  
Vol 22 (11) ◽  
pp. 1288-1295 ◽  
Author(s):  
Nimmagadda Srinivas ◽  
Lakshmi Narasu ◽  
B. Prabha Shankar ◽  
Ramesh Mullangi
Keyword(s):  
Human Plasma ◽  
Clinical Pharmacokinetic ◽  
Pharmacokinetic Study ◽  
Internal Standard ◽  
Hplc Method ◽  
Development And Validation

Development and Validation of an HPLC Method for Simultaneous Detection and Quantification of Paracetamol and Etodolac in Human Plasma and Its Application to a Pharmacokinetic Study

2013 ◽  
Vol 96 (3) ◽  
pp. 573-579 ◽  
Author(s):  
Bapi Gorain ◽  
Hira Choudhury ◽  
Utpal Nandi ◽  
Ayan Das ◽  
Shubhasis Dan ◽  
...  
Keyword(s):  
Human Plasma ◽  
Pharmacokinetic Study ◽  
Simultaneous Detection ◽  
Potassium Phosphate ◽  
Internal Standard ◽  
Accurate Method ◽  
Hplc Method ◽  
Healthy Human ◽  
Human Volunteers ◽  
Development And Validation

Abstract A simple, reproducible, and feasible RP-HPLC method has been developed for simultaneous determination of two commonly used drugs, paracetamol (PCM) and etodolac (EDL), in human plasma. In this specific and accurate method, tinidazole was used as an internal standard. Chromatographic separation was achieved on a Hiber C18 250 × 4.6 mm id, 5 μm particle size, column using the isocratic mobile phase 10 mM potassium phosphate buffer (adjusted to pH 7.5)–acetonitrile (70 : 30, v/v) at a flow rate of 1 mL/min. Detection was at 235 nm. The linear concentration range of the assay was 0.100 to 50.00 μg/mL for both analytes, and the linear regression correlation coefficient was (r2 > 0.99). The recovery of PCM and EDL were 94.03 and 88.27%, respectively. The method was validated for specificity, linearity, precision, accuracy, reproducibility, and stability. The intraday and interday precision and accuracy values for PCM and EDL met the acceptance criteria of U.S. Food and Drug Administration guidelines. PCM and EDL were stable in a battery of stability studies, viz., bench top, dry extract, and freeze-thaw cycles. This developed and validated method was successfully applied to quantitatively assess the PCM and EDL for the first time in human plasma obtained from a pharmacokinetic study performed with 12 healthy human volunteers.

Validated HPLC Method for Quantification of a Novel Trk Inhibitor, Larotrectinib in Mice Plasma: Application to a Pharmacokinetic Study

Drug Research ◽  
2020 ◽  
Vol 70 (02/03) ◽  
pp. 101-106
Author(s):  
Harsha K. Tripathy ◽  
S.V. Nair Manju ◽  
Ashok Zakkula ◽  
Ram Murthi Bestha ◽  
Sreekanth Dittakavi ◽  
...  
Keyword(s):  
Pharmacokinetic Study ◽  
High Performance ◽  
Wave Length ◽  
Internal Standard ◽  
Hplc Method ◽  
Long Term Storage ◽  
Development And Validation ◽  
Orally Active ◽  
Regulatory Guideline

AbstractLarotrectinib, is an orally active novel small molecule approved for the treatment of solid tumors in pediatrics and adult patients. It acts by inhibiting tropomyosin receptor kinase. In this paper, we report the development and validation of a high-performance liquid chromatography (HPLC) method for the quantitation of larotrectinib in mice plasma as per the FDA regulatory guideline. Plasma samples processing was accomplished through simple protein precipitation using acetonitrile enriched with internal standard (IS, enasidenib). The chromatographic analysis was performed using a gradient mobile phase comprising 10 mM ammonium acetate and acetonitrile at a flow-rate of 0.8 mL/min on an X-Terra Phenyl column. The UV detection wave length was set at λmax 262 nm. Larotrectinib and the IS eluted at 3.85 and 6.60 min, respectively with a total run time of 8.0 min. The calibration curve was linear over a concentration range of 0.20–5.00 μg/mL (r2=≥0.992). The intra- and inter-day precision and accuracy results were within the acceptable limits. Results of stability studies indicated that larotrectinib was stable on bench-top, in auto-sampler, up to three freeze/thaw cycles and long-term storage at −80°C. The validated HPLC method was successfully applied to a pharmacokinetic study in mice.

Simple and sensitive HPLC method for determination of amrubicin and amrubicinol in human plasma: application to a clinical pharmacokinetic study

2009 ◽  
pp. n/a-n/a ◽  
Author(s):  
Reiko Ando ◽  
Yoshinori Makino ◽  
Tomohide Tamura ◽  
Noboru Yamamoto ◽  
Rena Nishigaki ◽  
...  
Keyword(s):  
Human Plasma ◽  
Clinical Pharmacokinetic ◽  
Pharmacokinetic Study ◽  
Hplc Method

scholarly journals Development and validation of a rapid UHPLC-MS/MS method for the determination of fenofibric acid in human plasma: Application to a pharmacokinetic study of fenofibrate tablet in Chinese subjects

2020 ◽  
Author(s):  
Xiaorong Wu ◽  
Yankai Wang ◽  
Binbin Liang ◽  
Honghai Wu ◽  
Liying Wu ◽  
...  
Keyword(s):  
Human Plasma ◽  
Pharmacokinetic Study ◽  
High Performance ◽  
Multiple Reaction Monitoring ◽  
Internal Standard ◽  
Fenofibric Acid ◽  
The Matrix ◽  
Liquid Chromatography Tandem Mass ◽  
Development And Validation ◽  
Chinese Subjects

AbstractAn ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS) method was developed to determine the fenofibric acid (FA) in human plasma and applied to a pharmacokinetic study of fenofibrate tablet (Lipanthyl® supra, 160 mg) on Chinese subjects which had not been reported. Bezafibrate was used as an internal standard (IS), and the plasma samples were precipitated by methanol. Multiple reaction monitoring (MRM) mode was used to quantitatively analyzed FA m/z 317.2 → 230.7 and the IS m/z 360.0 → 274.0 in the electrospray ionization (ESI) negative interface. The calibration curves were linear over the range of 50–30,000  ng/mL (r2  ≥  0.996). The intra-day and inter-day precision (coefficient of variation, CV%) was less than 2.7 and 2.5%, respectively. The accuracy (relative error, RE%) ranged from −4.5 to 6.9%. The average recovery was higher than 86.2%, and the matrix effect was between 95.32 and 110.55%. The simple, rapid, and selectivity method was successfully applied to the pharmacokinetic study of fenofibrate tablets on Chinese subjects.

Development and Validation of an RP-HPLC Method for Determination of Atorvastatin and its Hydroxyl Metabolites in Human Plasma

2020 ◽  
Vol 16 (3) ◽  
pp. 238-245
Author(s):  
Dagmara Sowińska ◽  
Alicja Pogorzelska ◽  
Marlena Rakicka ◽  
Justyna Sznura ◽  
Justyna Janowska ◽  
...  
Keyword(s):  
Human Plasma ◽  
Internal Standard ◽  
Hplc Method ◽  
Active Metabolites ◽  
Peak Separation ◽  
Rp Hplc ◽  
Increased Risk ◽  
Relative Standard ◽  
Development And Validation

Background: Atorvastatin (AT) belongs to cholesterol-lowering agents, commonly used in patients with an increased risk of cardiovascular disease. The drug, as well as its hydroxyl metabolites, exhibit pharmacological activity, and their plasma levels may be helpful in the assessment of the therapeutic effectiveness. Objective: Development and validation of a fast and reproducible RP-HPLC method with UV detection for the simultaneous determination of atorvastatin and its active metabolites, para-hydroxy-atorvastatin (p-OH-AT) and ortho-hydroxy-atorvastatin (o-OH-AT) in human plasma. Methods: Optimal conditions of chromatographic separation of the analytes, as well as rosuvastatin, chosen as an internal standard, were studied. The absorbance of the compounds was measured at λ=248 nm. Validation of the method was performed. The usefulness of the method was confirmed for determination of the analytes in plasma of patients treated with the drug. Results: Total peak separation was achieved at LiChrospher 100 RP-18 column with a mobile phase composed of methanol and water (1:1,v:v) and a flow rate of 1.2 ml/min. The method was linear in the ranges of 0.025 - 1.0 μg/ml for AT, o-OH-AT and p-OH-AT. Intra- and inter-assay precision expressed as relative standard deviation was ≤13% for AT, ≤12% for p-OH-AT and ≤11% for o-OH-AT. Intraand inter-day accuracy of the method, expressed as a relative error, was ≤15%. Conclusion: The elaborated HPLC method is specific, repeatable, reproducible, adequately accurate and precise and fulfills the validation requirements for the bioanalytical method. The method was successfully applied for analysis of atorvastatin and its o-hydroxy metabolite in plasma of patients treated with the drug.

Sign in / Sign up

Export Citation Format

Share Document