Development and validation of high performance liquid chromatographic method for the determination of pyrazinamide in human plasma

Siddhartha, T. Sriram; Prasanthi, B.; Santosh, Tata; Ratna, J. Vijaya

doi:10.1016/j.jopr.2013.01.023

Cited by 8 publications

(7 citation statements)

References 6 publications

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“…To ensure that there was no interference of endogen matrix found in plasma sample or metabolite of rifampicin, it was necessary to evaluate chromatograms of blank plasma and plasma of subject after consuming rifampicin tablet [28,30]. Fig.…”

Section: Results Of Bioequivalence Studymentioning

confidence: 99%

Method Validation of Rifampicin Analysis in Human Plasma and Its Application in Bioequivalence Study

Lukitaningsih¹,

Jannah²,

Pebriana³

et al. 2019

Int J App Pharm

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Objective: This research aims to validate the method for rifampicin analysis in plasma by using High-Performance Liquid Chromatography (HPLC) that can be used to study the bioequivalence of a generic tablet of rifampicin 450 mg “X” marketed in Indonesia. Methods: Bioequivalence test was analysed using HPLC equipped with UV-Vis detector at 377 nm. The mobile phase used was acetonitrile-phosphate buffer pH 6.8 (45:55) delivered at a flow rate of 1.5 ml/min. Bioequivalence test was conducted on a limited number of subjects (n=8). The subjects were divided into two groups randomly. The pharmacokinetic profiles of the test tablet and reference tablet were statistically calculated using SPSS program to see the test tablet and reference tablet were bioequivalence or not. Results: The developed HPLC method for rifampicin analysis in plasma was sufficiently valid based on the International Conference on Harmonization (ICH) and European Medicines Agency (EMA) guideline, with precision and accuracy values were % Relative Standard Deviation (% RSD = 1.40–13.04) and % Recovery (86.24–102.13), respectively. Meanwhile, the method was linear over studied concentration (0.05 to 10.26 µg/ml) with a coefficient of determination (R2) = 0.9984. The method also had good stability and sensitivity. The result of statistical calculation showed that the generic rifampicin tablet X was bioequivalence toward the reference tablet Rimactan 450 mg. Conclusion: The test rifampicin tablet that was, the generic tablet “X” was bioequivalence toward the reference rifampicin tablet “Rimactan”.

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Section: Results Of Bioequivalence Studymentioning

confidence: 99%

Method Validation of Rifampicin Analysis in Human Plasma and Its Application in Bioequivalence Study

Lukitaningsih¹,

Jannah²,

Pebriana³

et al. 2019

Int J App Pharm

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“…The limit of quantification was 0.025 mg/liter. Rifampin and meropenem concentrations were quantified by high-performance liquid chromatography (HPLC) methods as previously described and modified for CAMHB (50,51). The assays were linear (r 2 Ͼ 0.999) over concentrations from 1 to 15 mg/liter and from 5 to 150 mg/liter, respectively.…”

Section: Methodsmentioning

confidence: 99%

Polymyxin B in Combination with Rifampin and Meropenem against Polymyxin B-Resistant KPC-Producing Klebsiella pneumoniae

Diep

Jacobs

Sharma

et al. 2017

Antimicrob Agents Chemother

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Safe and effective therapies are urgently needed to treat polymyxinresistant KPC-producing Klebsiella pneumoniae infections and suppress the emergence of resistance. We investigated the pharmacodynamics of polymyxin B, rifampin, and meropenem alone and as polymyxin B-based double and triple combinations against KPC-producing K. pneumoniae isolates. The rates and extents of killing with polymyxin B (1 to 128 mg/liter), rifampin (2 to 16 mg/liter), and meropenem (10 to 120 mg/liter) were evaluated against polymyxin B-susceptible (PB s ) and polymyxin B-resistant (PB r ) clinical isolates using 48-h static time-kill studies. Additionally, humanized triple-drug regimens of polymyxin B (concentration at steady state [C ss ] values of 0.5, 1, and 2 mg/liter), 600 mg rifampin every 12 or 8 h, and 1 or 2 g meropenem every 8 h dosed as an extended 3-h infusion were simulated over 48 h by using a one-compartment in vitro dynamic infection model. Serial bacterial counts were performed to quantify the pharmacodynamic effect. Population analysis profiles (PAPs) were used to assess the emergence of polymyxin B resistance. Monotherapy was ineffective against both isolates. Polymyxin B with rifampin demonstrated early bactericidal activity against the PB s isolate, followed by regrowth by 48 h. Bactericidal activity was sustained at all polymyxin B concentrations of Ն2 mg/liter in combination with meropenem. No two-drug combinations were effective against the PB r isolate, but all simulated triple-drug regimens showed early bactericidal activity against both strains by 8 h that was sustained over 48 h. PAPs did not reveal the emergence of resistant subpopulations. The triple-drug combination of polymyxin B, rifampin, and meropenem may be a viable consideration for the treatment of PB r KPC-producing K. pneumoniae infections. Further investigation is warranted to optimize triple-combination therapy.

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“…Furthermore, the analysis of SUV alone in pharmaceutical products has been described using an HPLC method . There have been reports of the use of certain bioanalytical HPLC methods for the analysis of SUV alone in human and rabbit plasma samples. , For the analysis of SUV alone in blood and urine samples, reports of the bioanalytical approaches LC-MS/MS and LC-quadrupole/time-of-flight–MS (LC-Q/TOF-MS) , have also been made. A bioanalytical method utilizing LC-MS/MS has also been documented for the simultaneous analysis of SUV and 16 distinct benzodiazepines in the whole blood specimen .…”

Section: Introductionmentioning

confidence: 99%

A Simple, Sensitive, and Greener HPLC-DAD Method for the Simultaneous Analysis of Two Novel Orexin Receptor Antagonists

Iqbal,

Haq,

Kalam

et al. 2024

ACS Omega

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The orexin receptor antagonist (ORA) is one of the new psychopharmacological agents used in the treatment of insomnia. There are currently no documented greener high-performance liquid chromatography-diode array detector (HPLC-DAD) methods for the analysis of ORA antagonists, lemborexant (LMB) and suvorexant (SUV) simultaneously. Therefore, in this study, a simple, sensitive, and greener HPLC-DAD method has been developed for the simultaneous quantitative analysis of LMB and SUV in bulk and laboratory-prepared mixture. The developed method was validated for numerous validation parameters and evaluated for greenness. The C 18 Waters Spherisorb CN (4.6 × 250 mm 2 ; 5 μm) column was used for the chromatographic separation. The mobile phase composition was ethanol: 10 mM KH 2 PO 4 buffer in a ratio of (60:40 v/v). The DAD detection was performed at 253 nm using a Waters DAD detector. The greenness was evaluated using the analytical Eco-Scale (AES), ChlorTox, and analytical GREEnness (AGREE) techniques. The calibration curves showed excellent linearity for LMB and SUV between the concentration range of 125−5000 ng/ mL and 250−10,000 ng/mL, respectively. In addition, the proposed HPLC-DAD method was accurate, precise, robust, highly sensitive, and greener. AES, ChlorTox, and AGREE scales were predicted by the HPLC-DAD method to be 91, 1.14 g, and 0.79, respectively, showing an excellent greenness profile. The greener HPLC-DAD method was successfully used to analyze both medicines quantitatively in bulk and laboratory-prepared synthetic mixtures. The findings of this study indicated that the proposed HPLC-DAD method may be consistently applied to evaluate LMB and SUV in bulk and dosage forms.

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Development and validation of high performance liquid chromatographic method for the determination of pyrazinamide in human plasma

Cited by 8 publications

References 6 publications

Method Validation of Rifampicin Analysis in Human Plasma and Its Application in Bioequivalence Study

Method Validation of Rifampicin Analysis in Human Plasma and Its Application in Bioequivalence Study

Polymyxin B in Combination with Rifampin and Meropenem against Polymyxin B-Resistant KPC-Producing Klebsiella pneumoniae

A Simple, Sensitive, and Greener HPLC-DAD Method for the Simultaneous Analysis of Two Novel Orexin Receptor Antagonists

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