Simultaneous quantitative determination of zidovudine and nevirapine in human plasma using isocratic, reverse phase high performance liquid chromatography

Kabra, V.; Agrahari, Vivek; Karthikeyan, Chandrabose; Trivedi, Piyush

doi:10.4314/tjpr.v8i1.14715

Cited by 11 publications

(9 citation statements)

References 17 publications

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“…The approaches suggested by Singh and Bakshi were adopted for these studies [6,7,[25][26][27]. A minimum of four samples were generated for every stress condition, viz., the blank solution stored under normal conditions, the blank subjected to stress in the same manner as this drug (trandolapril), zero time sample containing this drug (which was stored under normal conditions) and this drug solution subjected to stress treatment.…”

Section: Stress Studiesmentioning

confidence: 99%

A Validated UPLC Method Used for the Determination of Trandolapril and its Degradation Products as per ICH Guidelines

Sahu¹,

Karthikeyan²,

Moorthy³

et al. 2011

CPA

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In this present research work, a new stability indicating assay method was developed for the estimation of trandolapril and its degraded products by isocratic reversed phase chromatographic technique using ultra performance liquid chromatography. The Study involves a comprehensive stress testing of trandolapril which was carried out according to ICH guideline Q1A (R2). The drug was subjected to acid (0.1M HCl), neutral (water) and alkaline (0.1M NaOH) hydrolysis at 80ºC, as well as the drug was kept at room temperature with H 2 O 2 for oxidative decomposition. Photolysis was carried out by exposing this drug into sunlight (60,000-70,000 lux) for 2 days. Additionally, the solid drug was subjected to 50ºC for 60 days in a hot air oven for thermal degradation. The results reveal that the degradation products of this drug were found in alkaline medium, acidic conditions and also in neutral hydrolysis. Separation of this drug and its degradation products (from various stress conditions) was successfully achieved on a BEH (bridged ethylene hybrid) C18 column utilizing water-acetonitrile in the ratio of 20:80. The flow rate and the detection wavelength for the analysis were 0.2 mL/min and 215 nm, respectively. The method was validated and the response was found to be linear in this drug concentration range of 0.431-2.155 M/mL (10-50 g/mL). The mean values (± %RSD) of slope, intercept and correlation coefficient were 2674262 (±0.9), 14924 (±1.02) and 0.9999 (±0.08), respectively. The %RSD values for intra-and inter-day precision studies were <1% and <2%, respectively. The recovery of this drug ranged between 98.93-100.18% from a mixture of degradation products. The obtained results reveal that the developed method is specific to this drug and selective to the degradation products.

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Section: Stress Studiesmentioning

confidence: 99%

A Validated UPLC Method Used for the Determination of Trandolapril and its Degradation Products as per ICH Guidelines

Sahu¹,

Karthikeyan²,

Moorthy³

et al. 2011

CPA

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“…[11] This allows HIV to become ZDV-resistant over time, and for this reason ZDV is usually used in conjunction with other NRTIs and anti-viral drugs to prolong the lifespan of AIDS patients. [16][17][18][19][20][21][22][23] Only Fan et al described a method for simultaneous determination of ZDV, LMV, and NVR in human plasma by HPLC-UV based on using an ion-pairing agent for chromatographic separation which is not user friendly due to multistep process with the treatment of number of reagents and solid-phase extraction (SPE) for sample preparation which is very costly as well as having a longer runtime for analysis. Nevirapine (NVR) is in the class of NNRTI, and is recommended for antiretroviral therapy.…”

Section: Introductionmentioning

confidence: 99%

“…[15] Quite a number of techniques have already been reported by different investigators for the quantification of ZDV/LMV/NVR in human plasma by high performance liquid chromatography (HPLC) or liquid chromatography-tandem mass spectrometry (LC-MS/MS) individually. [16][17][18][19][20][21][22][23] Only Fan et al described a method for simultaneous determination of ZDV, LMV, and NVR in human plasma by HPLC-UV based on using an ion-pairing agent for chromatographic separation which is not user friendly due to multistep process with the treatment of number of reagents and solid-phase extraction (SPE) for sample preparation which is very costly as well as having a longer runtime for analysis. [24] In the present study, a simple, accurate, sensitive method has been developed for simultaneous determination of ZDV, LMV, and NVR in human plasma by HPLC with UV detection where simple mobile phase composition without any ion-pairing agent was used for chromatographic separation.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of an HPLC‐UV method for simultaneous determination of zidovudine, lamivudine, and nevirapine in human plasma and its application to pharmacokinetic study in human volunteers

Nandi

Das

Roy

et al. 2012

Drug Testing and Analysis

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A simple, rapid, and sensitive high performance liquid chromatographic method with UV detection has been developed and validated according to the FDA guidelines for the quantitation of zidovudine (ZDV), lamivudine (LMV), and nevirapine (NVR) in human plasma. The sample was prepared by simple liquid-liquid extraction. Chromatographic separation was carried out in a Hypersil BDS, C(18) column (250 mm × 4.6 mm; 5 µm particle size) with simple mobile phase composition of 0.1 M ammonium acetate buffer in 0.5% acetic acid, v/v and methanol (40:60, v/v) at a flow rate of 0.85 ml min(-1) where detector was set at 270 nm with a total run time of 10 min which is very short for simultaneous estimation of three analytes in plasma. The method was linear over the concentration range of 50-3000, 50-2000 and 10-3000 ng ml(-1) with lower limit of quantifications (LLOQ) of 50, 50, and 10 ng ml(-1) for ZDV, LMV, and NVR, respectively. Accuracy and precision values of both within-run and between-run obtained from six different sets of three quality control (QC) samples along with the LLOQ analyzed in separate occasions for all the analytes ranged from 94.47-99.71% and 0.298-3.507%, respectively. Extraction recovery of analytes in plasma samples was above 90.16%. In stability tests, all the analytes in human plasma were stable during storage and assay procedure. The developed and validated method was successfully applied to quantitative determination of the three analytes in plasma for pharmacokinetic study in 12 healthy human volunteers.

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“…The concentration of nevirapine in the plasma samples was analyzed by modified reported methods (Hollanders et al, 2000;Kabra et al, 2009;Minzi & Ngaimisi, 2010). The HPLC apparatus consisted of Jasco PU-980 Intelligent HPLC pump (Jasco, Japan) equipped with a Jasco UV-975 Intelligent UV/VIS detector (Jasco, Japan), an autosampler Jasco AS-950-10 Intelligent sample (Jasco, Japan), a Jasco Borwin chromatography software (version 1.50) integrator software and a LCGC Qualisil BDS C18 (4.6 mm Â 250 mm and 5 mm particle size) column.…”

Section: Hplc Analysismentioning

confidence: 99%

“…Aliquots of 3 ml were withdrawn at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4 and 5 hours time intervals from the beaker and suitably diluted further. The absorbance was measured using a UV-visible spectrophotometer at a wavelength of 283 nm (Kabra et al, 2009;Mandloi et al, 2009). The amount of drug diffused (%) was calculated against time and plotted on a graph.…”

Section: Ex-vivo Intestinal Permeability Studiesmentioning

confidence: 99%

Role of lipid-based excipients and their composition on the bioavailability of antiretroviral self-emulsifying formulations

Chudasama

Patel

Nivsarkar³

et al. 2014

Drug Delivery

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The objective of this study was to develop self-emulsifying drug delivery system (SEDDS) to improve solubility and enhance the oral absorption of the poorly water-soluble drug, nevirapine. This lipid-based formulation may help to target the drug to lymphoid organs where HIV-1 virus resides mainly. The influence of the oil, surfactant and co-surfactant types on the drug solubility and their ratios on forming efficient and stable SEDDS were investigated in detail. Two SEDDS (F1 and F2) were prepared and characterized by morphological observation, droplet size and zeta potential determination, cloud point measurement and in vitro diffusion study. The influence of droplet size on the absorption from formulations with varying concentration of oil and surfactant was also evaluated from two self-emulsifying formulations. Oral bioavailability of nevirapine SEDDS was checked by using rat model. Results of diffusion rate and oral bioavailability of nevirapine SEDDS were compared with marketed suspension. The absorption of nevirapine from F1 and F2 showed 1.92 and 1.98-fold increase (p50.05) in relative bioavailability, respectively, compared with that of the suspension. There was no statistical significant difference (p50.05) between F1 and F2 in their AUC and C max . This indicated that there was apparent poor correlation between the droplet size and in vivo absorption. However, nevirapine in SEDDS showed higher ex vivo stomach and intestinal permeability and in vivo absorption than the marketed suspension, suggesting that the SEDDS may be a useful delivery system for targeting nevirapine to lymphoid organs.

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Simultaneous quantitative determination of zidovudine and nevirapine in human plasma using isocratic, reverse phase high performance liquid chromatography

Cited by 11 publications

References 17 publications

A Validated UPLC Method Used for the Determination of Trandolapril and its Degradation Products as per ICH Guidelines

A Validated UPLC Method Used for the Determination of Trandolapril and its Degradation Products as per ICH Guidelines

Development and validation of an HPLC‐UV method for simultaneous determination of zidovudine, lamivudine, and nevirapine in human plasma and its application to pharmacokinetic study in human volunteers

Role of lipid-based excipients and their composition on the bioavailability of antiretroviral self-emulsifying formulations

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