Development and validation of bioanalytical liquid chromatography–tandem mass spectrometry method for the estimation of pentoxifylline in human plasma: Application for a comparative pharmacokinetic study

Dodda, Sireesha; Ajitha, M.; Polagani, Srinivasa Rao; Kandhagatla, Raj Narayana

doi:10.1177/1469066718817929

Cited by 3 publications

(3 citation statements)

References 25 publications

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“…assay results. 26,27 The assessment depends on the use of individual peak areas, a calculation of subunit-specific DAR values, and an extrapolation of DARs to one intact molecule DAR value (see . Supplementary Table S2 lists representative peak areas observed from the DFA method for the unconjugated and conjugated subunits of the cysteinelinked auristatin ADC, which in turn can be used to infer an average DAR value of 4.2.…”

Section: New Methods For Adc Characterizationmentioning

confidence: 99%

High sensitivity LC-MS profiling of antibody-drug conjugates with difluoroacetic acid ion pairing

Nguyen

Smith

Rzewuski

et al. 2019

mAbs

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Reversed-phase liquid chromatography (RPLC) separations of proteins using optical detection generally use trifluoroacetic acid (TFA) because it is a strong, hydrophobic acid and a very effective ion-pairing agent for minimizing chromatographic secondary interactions. Conversely and in order to avoid ion suppression, analyses entailing mass spectrometry (MS) detection is often performed with a weaker ion-pairing modifier, like formic acid (FA), but resolution quality may be reduced. To gain both the chromatographic advantages of TFA and the enhanced MS sensitivity of FA, we explored the use of an alternative acid, difluoroacetic acid (DFA). This acid modifier is less acidic and less hydrophobic than TFA and is believed to advantageously affect the surface tension of electrospray droplets. Thus, it is possible to increase MS sensitivity threefold by replacing TFA with DFA. Moreover, we have observed DFA ion pairing to concomitantly produce higher chromatographic resolution than FA and even TFA. For this reason, we prepared and used MS-quality DFA in place of FA and TFA in separations involving IdeS digested, reduced NIST mAb and a proprietary antibody-drug conjugate (ADC), aiming to increase sensitivity, resolution and protein recovery. The resulting method using DFA was qualified and applied to two other ADCs and gave heightened sensitivity, resolution and protein recovery versus analyses using TFA. This new method, based on a purified, trace metal free DFA, can potentially become a state-of-the-art liquid chromatography-MS technique for the deep characterization of ADCs.

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Section: New Methods For Adc Characterizationmentioning

confidence: 99%

High sensitivity LC-MS profiling of antibody-drug conjugates with difluoroacetic acid ion pairing

Nguyen

Smith

Rzewuski

et al. 2019

mAbs

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“…In addition to a narrow linear range, other HPLC-UV concentration determination methods of PTX also suffer from long running time, a cumbersome pre-treatment process and large injection volume. [10][11][12][13] The literature reports LC-MS/MS methods for determining the concentration of PTX. However, this method is relatively cumbersome due to pre-treatment methods such as solid-phase extraction (SPE) and liquid-liquid extraction (LLE).…”

Section: Introductionmentioning

confidence: 99%

Development and Validation a UPLC-MS/MS Method for Quantification of Pentoxifylline in Beagle Plasma: Application for Pharmacokinetic Study of Food Effect

Xu,

Gao,

Zhu

et al. 2023

DDDT

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Purpose To develop an UPLC-MS/MS method for the quantitative analysis of pentoxifylline in beagle dog plasma and apply it to a pharmacokinetic study of food effect. Methods Sample separation was achieved using a Kinetex Phenyl-Hexyl column (50 × 2.1 mm, 1.7 μm) with a gradient elution program in 5.5 min after a simple protein precipitation with methanol. Using the mobile phase that made up by 0.2% formic acid and 5mM ammonium formate water (A) and methanol (B). Quantitation was carried out using the positive ionization mode with multiple reaction monitoring (MRM). A randomized, single-dose, two-period crossover study was conducted in six fasted or fed beagles that received 400 mg pentoxifylline sustained-release tablets (Brand name: Shuanling™, CSPC Pharmaceutical Group). WinNonlin ® software was used to calculate pharmacokinetic parameters. Results The linear calibration range was 2–1000 ng/mL (r 2 > 0.99). Both intra- and inter-batch precision were less than 6.27%, and the accuracy ranged from 88.65% to 97.18%. Pentoxifylline was readily absorbed in fasted and fed dogs administered a dose of 400 mg (t max :1.54h vs 1.83h). Compared to the fasted group, the AUC 0→t and C max in the fed group increased by 1.71-fold and 1.30-fold, respectively. In the fasted group, the AUC 0→t and C max values were 4684.08 h•ng/mL and 2402.33 ng/mL, respectively. In the fed group, these values were 8027.75 h•ng/mL and 3119.67 ng/mL. The difference in AUC 0-t between the fed and fasted group was statistically significant. Conclusion The novel optimized UPLC-MS/MS assay is an effective tool for the determination of pentoxifylline and has been successfully applied in pharmacokinetic studies of pentoxifylline in beagle dogs. The administration of pentoxifylline sustained-release tablets with food significantly increased the area under the time curve, and it is recommended that they should be administered during or shortly after feeding.

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“…Different methods for PTX and MLT determination were reported. For example, PTX and MLT were determined in biological samples by High Performance Liquid Chromatography (HPLC) [28][29][30][31] , Liquid Chromatography-Mass Spectrometry (LC-MS) [32,33] and electrochemical methods [34][35][36][37] . For analysis of both drugs in pharmaceutical formulations HPLC [38][39][40][41] , Thin-Layer Chromatography (TLC) [42,43] , spectral [44][45][46][47] and electrochemical [34,36,37,48] methods were used.…”

mentioning

confidence: 99%

Simultaneous Determination of Pentoxifylline and Melatonin in Spiked Plasma Samples by Reverse Phase High Performance Liquid Chromatography Method

Smerikarova¹,

Bozhanov²,

Maslarska³

2022

IJPS

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Smerikarova et al.: High Performance Liquid Chromatography Determination of Pentoxifylline and MelatoninDue to their anti-inflammatory and antioxidant properties, pentoxifylline and melatonin have been considered by many authors as potential adjuvants in coronavirus disease infection. The present study describes the development of a high performance liquid chromatography method with ultraviolet detection for the simultaneous determination of pentoxifylline and melatonin in spiked plasma samples. The chromatographic separation was performed isocratically at a temperature of 25°, using a LiChrosorb ® reverse phase-18 (125×4.0 mm, 5 μm) as stationary phase. The mobile phase consists of water and acetonitrile in a ratio of 80:20 v/v. Under optimal chromatographic conditions, for both pentoxifylline and melatonin, the number of theoretical plates was >2000, peak asymmetry was <1.3 and resolution factors were >2. The relative standard deviations for pentoxifylline and melatonin for both intra-day and interday not exceeded 4 % and recoveries were in the ranges 99.46 %-102.51 % for pentoxifylline and 96.02 %-102.85 % for melatonin.

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Development and validation of bioanalytical liquid chromatography–tandem mass spectrometry method for the estimation of pentoxifylline in human plasma: Application for a comparative pharmacokinetic study

Cited by 3 publications

References 25 publications

High sensitivity LC-MS profiling of antibody-drug conjugates with difluoroacetic acid ion pairing

High sensitivity LC-MS profiling of antibody-drug conjugates with difluoroacetic acid ion pairing

Development and Validation a UPLC-MS/MS Method for Quantification of Pentoxifylline in Beagle Plasma: Application for Pharmacokinetic Study of Food Effect

Simultaneous Determination of Pentoxifylline and Melatonin in Spiked Plasma Samples by Reverse Phase High Performance Liquid Chromatography Method

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