Bioanalytical method development and validation of milnacipran in rat plasma by LC–MS/MS detection and its application to a pharmacokinetic study

Kanala, Kanchanamala; Hwisa, Nagiat T.; Chandu, Babu Rao; Katakam, Prakash; Mukkanti, K.; Challa, B.R.; Bhavyasri, Khagga

doi:10.1016/j.jpha.2013.03.009

Cited by 8 publications

(5 citation statements)

References 14 publications

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“…Our observations based on the IV administration are fairly similar to a report published by Uchida and colleagues [ 42 ], who studied the pharmacokinetics of milnacipran in rats at 20 mg/kg dose and reported a half-life of 2.3 h. In the same study, the half-life of milnacipran after oral, intranasal, and intraduodenal administration (at 20 mg/kg dose) was reported to be shorter—76.2, 67.9, and 47.1 min, respectively. Curiously, another research group reported a substantially longer half-life of 6.7 h for IV-administered milnacipran in rats at 4.5 mg/kg dose [ 16 ]. Additional evidence in support of our observations, i.e., shorter half-life of milnacipran in rodents, could be drawn from pharmacokinetic studies of levomilnacipran, because both enantiomers of milnacipran have very similar pharmacokinetic profiles [ 43 ].…”

Section: Discussionmentioning

confidence: 99%

“…Curiously, there is a paucity of published studies reporting systemic and brain pharmacokinetics of milnacipran in rodents. In our literature search, we only found one article describing the pharmacokinetics of milnacipran in rats [ 16 ] and two additional articles that studied levomilnacipran [ 17 , 18 ]. Based on this, the current study was designed to study milnacipran’s systemic and brain pharmacokinetics in mice and compare IV and IP routes of administration.…”

Section: Introductionmentioning

confidence: 99%

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Systemic and Brain Pharmacokinetics of Milnacipran in Mice: Comparison of Intraperitoneal and Intravenous Administration

Bagchi,

Nozohouri,

Ahn

et al. 2023

Pharmaceutics

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Milnacipran is a dual serotonin and norepinephrine reuptake inhibitor, clinically used for the treatment of major depression or fibromyalgia. Currently, there are no studies reporting the pharmacokinetics (PK) of milnacipran after intraperitoneal (IP) injection, despite this being the primary administration route in numerous experimental studies using the drug. Therefore, the present study was designed to investigate the PK profile of IP-administered milnacipran in mice and compare it to the intravenous (IV) route. First a liquid chromatography–mass spectrometry (LC-MS/MS) method was developed and validated to accurately quantify milnacipran in biological samples. The method was used to quantify milnacipran in blood and brain samples collected at various time-points post-administration. Non-compartmental and PK analyses were employed to determine key PK parameters. The maximum concentration (Cmax) of the drug in plasma was at 5 min after IP administration, whereas in the brain, it was at 60 min for both routes of administration. Curiously, the majority of PK parameters were similar irrespective of the administration route, and the bioavailability was 92.5% after the IP injection. These findings provide insight into milnacipran’s absorption, distribution, and elimination characteristics in mice after IP administration for the first time and should be valuable for future pharmacological studies.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Systemic and Brain Pharmacokinetics of Milnacipran in Mice: Comparison of Intraperitoneal and Intravenous Administration

Bagchi,

Nozohouri,

Ahn

et al. 2023

Pharmaceutics

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“…Targeted metabolomics (Milnacipran measurement) was performed by LC-MS/MS as described previously. 59 Briefly, cecal samples (100 mg) from germ-free (GF) and WT mice were dissolved in 1 mL of ice-cold water and sonicated for 10 min, and the supernatant was collected by centrifugation. Methyl tert -butyl ether was then added and vortexed for 3 min, followed by centrifugation at 13,000 rpm for 10 min at 4°C.…”

Section: Methodsmentioning

confidence: 99%

Gut microbe-derived milnacipran enhances tolerance to gut ischemia/reperfusion injury

Deng¹,

Hu²,

Lin³

et al. 2023

Cell Reports Medicine

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“…The ratio of gallic acid concentration with and without biomatrix was used to determine the extraction efficiency of gallic acid. According to FDA guidelines, drug recovery does not have to be perfect, but it should be consistent, accurate, and repeatable [24,25].…”

Section: Recovery Studymentioning

confidence: 99%

A Novel Rp-HPLC Gradient Elution Technique for Bioanalytical Method Development and Validation for Estimating Gallic Acid in Wistar Rat Plasma

MANE

KILLEDAR²,

MORE³

et al. 2023

Int J App Pharm

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Objective: Present study aimed to develop and validate a novel, unique, simple, quick, cost-effective, sensitive, specific, accurate, precise, rugged, and robust bioanalytical method for the quantification of gallic acid in rat plasma by reverse phase high-performance liquid chromatography (RP-HPLC) using gradient elution technique. Methods: The stationary phase was a Zorbax SB C18 5 µ (4.6*150) mm column, with the mobile phase being water with 0.1 percent formic acid (A): acetonitrile (ACN) with 0.08 percent formic acid (B). Gradient chromatographic method was used throughout this experiment from the point of view of the estimation of gallic acid from herbal formulations when present along with other phytoconstituents. So at the gradient method, all the present phytoconstituents has cleared off from the column and no any strongly adsorption of phytoconstituents occurred. The experiment was carried out at a flow rate of 1.0 ml/min at 30 °C utilising PDA detectors at 271 nm. The proposed method was validated for different parameters. Results: The approach was found to be linear in the concentration range of 0.5-100 µg/ml, with a r2 of 0.9998. There was not observed any interference of co-eluting peaks of endogenous compounds from the biological matrix at the same retention time (Rt) of gallic acid. The RSD (%) of intra and interday precision was found to be within acceptable limit. The overall % mean recovery was found to be 99.97%. LOD and LOQ were found to be 0.1 and 0.5 μg/ml, respectively. In terms of fluctuation in essential parameters and operating settings, the devised bioanalytical approach was shown to be rugged and resilient. Short-term, long-term, autosampler, bench-top, and freeze-thaw stability experiments revealed that gallic acid is stable. Conclusion: The developed method described in this report was found to be well within an acceptable range. Hence, in the future, this method can be used successfully for the estimation of gallic acid alone or in combination with another analyte or marker present in bulk or an extract containing various phytoconstituents in pharmacokinetic, bioequivalence, and therapeutic drug monitoring studies in clinical laboratories.

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Bioanalytical method development and validation of milnacipran in rat plasma by LC–MS/MS detection and its application to a pharmacokinetic study

Cited by 8 publications

References 14 publications

Systemic and Brain Pharmacokinetics of Milnacipran in Mice: Comparison of Intraperitoneal and Intravenous Administration

Systemic and Brain Pharmacokinetics of Milnacipran in Mice: Comparison of Intraperitoneal and Intravenous Administration

Gut microbe-derived milnacipran enhances tolerance to gut ischemia/reperfusion injury

A Novel Rp-HPLC Gradient Elution Technique for Bioanalytical Method Development and Validation for Estimating Gallic Acid in Wistar Rat Plasma

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