HPLC-UV method for the quantitation of nevirapine in biological matrices following solid phase extraction

Pav, Joseph W.; Rowland, Lois; Korpalski, Deborah J

doi:10.1016/s0731-7085(98)00312-4

Cited by 47 publications

(23 citation statements)

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“…Nevirapine concentrations were quantitated in plasma at Boehringer Ingelheim Pharmaceuticals (Ridgefield, CT) using a high-performance liquid chromatographic (HPLC) assay with ultraviolet (UV) detection 14 . The nevirapine assay limits of quantitation were 0.025 and 10 μg/mL.…”

Section: Bioanalyticsmentioning

confidence: 99%

Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection

Sabo¹,

Lamson²,

Leitz³

et al. 2000

AAPS PharmSci

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The purpose of this parallel treatment group, double-blind, multicenter study was to characterize the pharmacokinetics of nevirapine and lamivudine when coadministered to patients with the HIV -1 infection. This pharmacokinetic interaction study was nested within a larger Phase III clinical trial conducted to characterize the safety and efficacy of coadministered nevirapine and lamivudine. One hundred HIV -1 infected patients with CD4+ lymphocyte counts = 200 cells/mm 3 and who were on a background of) therapy were randomly assigned to be treated with either nucleoside + lamivudine + nevirapine or nucleoside + lamivudine + placebo. Each patient underwent blood sampling at defined times for the purpose of determining the concentration of nevirapine in plasma and lamivudine in serum under steady-state conditions. Each patient was also monitored closely for concomitant administration of other drugs, including ZDV, ddI, ddC, d4T and cotrimoxazole. The pharmacokinetics of nevirapine and lamivudine were characterized using nonlinear mixedeffects modeling. There were no reported serious adverse events during the 40-day pharmacokinetic study. The results of the modeling analysis revealed that nevirapine had no effect on the pharmacokinetics of lamivudine. Estimates of the apparent clearance for nevirapine (CL/F = 3.3 L/hour; 95% confidence interval [CI] 2.9 to 3.7 L/hour) and lamivudine (CL/F 27.6 L/hour; 95% CI 22 to 33.2 L/hour) were consistent with the values reported in earlier trials. However, the results also showed that concomitant administration of lamivudine with cotrimoxazole resulted in a 31% reduction in the apparent clearance of lamivudine, resulting in a 43% increase in the average steady-state lamivudine serum concentrations. These results indicate that chronic concurrent administration of cotrimoxazole with lamivudine may significantly affect the steady-state pharmacokinetics of lamivudine.

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Section: Bioanalyticsmentioning

confidence: 99%

Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection

Sabo¹,

Lamson²,

Leitz³

et al. 2000

AAPS PharmSci

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“…Several bioanalytical methods are reported to determine 3TC, d4T and NVP individually in different biological matrices like plasma [16][17][18][19][20][21][22][23][24], tissues and amniotic fluids [16], saliva [17], urine [18,20], cerebrospinal fluids [17,21] and serum [21,25]. Sensitive and selective methods [26][27][28][29][30][31][32][33][34][35][36] based on HPLC-UV and LC-MS/MS methodologies have also been developed for simultaneous analysis of these three drugs in combination with other NRTI, NNRTI or protease inhibitors as they have higher efficacy, acceptable toxicity and broader action range.…”

Section: Introductionmentioning

confidence: 99%

High throughput LC–MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma

Mistri

Jangid

Pudage

et al. 2007

Journal of Chromatography B

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“…Previously few methods [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] are available for analysis of NVP in formulations and bulk drug.Ch Venkata Reddiah et al 20 reported one HPLC method for analysis of NVP and its impurities. While developing method at initial stage of the methoddevelopment trials done with NH 4 H 2 PO 4, Sodium per chlorate buffer solution at different pH and acetonitrile as solvent and C18 column but the separation of NVP and Impurity-Ais not good.…”

Section: Resultsmentioning

confidence: 99%

High Resolution RP-HPLC Method for the Determination of Nevirapine and Associated Impurities

Phani¹,

Prasad²,

Mallu³

2015

Orient. J. Chem

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Objective of the present research work is to develop a sensitive, selective and accurate new RPHPLC method with UV detection and determination for estimation of Nevirapine (NVP)and its impurities in bulk drug. The separation and quantification was achieved with Kromosil C18 isocratic column, (150 mm × 4.6 mm i.d., particle size 3.5 µm, maintained at ambient temperature), HPLC system (Peak LC P7000), a mixture of 20% acetonitrile, 80% buffer (sodium per chlorate) (v/v), at pH of 4.8 and the flow rate was set at 1.0 ml/min. and UV detection at 220 nm. The retention time for NVP, Impurity-A and Impurity-B were found to be 5.5, 7.8, 3.4 min respectively. The method was validated for Linearity, Accuracy, and Precision. The Limit of detection of NVP, Impurity-A and Impurity-B were found to be 0.03, 0.03, 0.03(µg/ml) respectively.

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HPLC-UV method for the quantitation of nevirapine in biological matrices following solid phase extraction

Cited by 47 publications

References 0 publications

Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection

Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection

High throughput LC–MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma

High Resolution RP-HPLC Method for the Determination of Nevirapine and Associated Impurities

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