Simultaneous determination of lamivudine, stavudine and nevirapine in antiretroviral fixed dose combinations by high performance liquid chromatography

Kapoor, Namita; Khandavilli, Sateesh; Panchagnula, Ramesh

doi:10.1016/j.aca.2006.03.107

Cited by 34 publications

(18 citation statements)

References 9 publications

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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%

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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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Section: Resultsmentioning

confidence: 99%

“…Once the HPLC method development was over, validated the developed method as perICH and FDA [1][2][3][4][5] guidelines with parameters like, linearity, precision, accuracy and range, ruggedness, robustness etc.…”

Section: Methods Validationmentioning

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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“…A review of the literature shows that various conventional analytical methods including spectrophotometry, [1][2][3][4][5] high performance thin layer chromatography, 4 high performance liquid chromatography, [4][5][6][7][8][9][10][11][12][13] high performance liquid chromatography-mass spectrometry 14 and signal processing method 15 were reported for the analysis of ZID and LAM or their combination with other drugs in tablets, human serum and in drug dissolution studies.…”

Section: Introductionmentioning

confidence: 99%

Comparative Application of PLS and PCR Methods to Simultaneous Quantitative Estimation and Simultaneous Dissolution Test of Zidovudine - Lamivudine Tablets

Üstündağ

Dinç

Özdemir

et al. 2015

ACSi

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In the development strategies of new drug products and generic drug products, the simultaneous in-vitro dissolution behavior of oral dosage formulations is the most important indication for the quantitative estimation of efficiency and biopharmaceutical characteristics of drug substances. This is to force the related field's scientists to improve very powerful analytical methods to get more reliable, precise and accurate results for the quantitative analysis and dissolution testing of drug formulations. In this context, two new application of partial least squares (PLS) and principal component regression (PCR) were applied for the simultaneous quantitative estimation and dissolution testing of zidovudine (ZID) and lamivudine (LAM) in a tablet dosage form. The results obtained in this study strongly encourage us to use them for the quality control, the routine analysis and the dissolution test of the marketing tablets containing ZID and LAM drugs.

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“…3 Several analytical methods have been developed for analyzing nevirapine and other antiretroviral drugs including derivative UV spectrophotometry 4 and high performance thin layer chromatography (HPTLC). 5 High performance liquid chromatography (HPLC) has been widely used for determination of antiretrovirals in both biological fluids and pharmaceutical formulations, [6][7][8][9][10][11] hyphenated HPLC-MS [12][13][14][15][16][17] systems have also been introduced for the determination of antiretrovirals in plasma. Many of these methods require the use of expensive and hazardous chemicals which make the process complex, time consuming and costly.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a simple and rapid capillary zone electrophoresis method for determination of nnrti nevirapine in pharmaceutical formulations

Filho

Galdez²,

Silva

et al. 2011

J. Braz. Chem. Soc.

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Um método simples e rápido por eletroforese capilar foi desenvolvido e validado para a quantificação do inibidor não nucleosídeo da transcritase reversa (NNRTI) nevirapina, em medicamentos. A análise foi otimizada utilizando tampão fosfato de sódio 10 mmol L -1 , pH 2,5, voltagem aplicada de +25 kV, injeção hidrodinâmica a 0,5 psi por 5 s e detecção UV em 200 nm. Diazepam (50,0 µg mL -1 ) foi usado como padrão interno. Sob estas condições, nevirapina foi analisada em aproximadamente menos de 2,5 min. A curva analítica apresentou um coeficiente de correlação de 0,9994. Os limites de detecção e quantificação foram 1,4 µg mL -1 e 4,3 µg mL -1 , respectivamente. Precisões intra e inter-dia expressas como desvio padrão relativo foram 1,4% e 1,3%, respectivamente e a recuperação média foi de 100,81%. O fármaco foi submetido a testes de hidrólises (ácida, básica e neutra) e a estresse oxidativo. Não foi observada interferência por parte dos produtos de degradação, nem dos excipients na análise da nevirapina. Este método mostrou ser rápido, simples, preciso, exato e econômico para a determinação de nevirapina em produtos farmacêuticos e é apropriado para o controle de qualidade em análise de rotina uma vez que a eletroforese capilar oferece benefícios em termos de desenvolvimento rápido dos métodos e custos muito reduzidos de operação.A simple and fast capillary zone electrophoresis (CZE) method has been developed and validated for quantification of a non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, in pharmaceuticals. The analysis was optimized using 10 mmol L -1 sodium phosphate buffer pH 2.5, +25 kV applied voltage, hydrodynamic injection 0.5 psi for 5 s and direct UV detection at 200 nm. Diazepam (50.0 µg mL -1 ) was used as internal standard. Under these conditions, nevirapine was analyzed in approximately less than 2.5 min. The analytical curve presented a coefficient of correlation of 0.9994. Limits of detection and quantification were 1.4 µg mL -1 and 4.3 µg mL -1 , respectively. Intra-and inter-day precision expressed as relative standard deviations were 1.4% and 1.3%, respectively and the mean recovery was 100.81%. The active pharmaceutical ingredient was subjected to hydrolysis (acid, basic and neutral) and oxidative stress conditions. No interference of degradation products and tablet excipients were observed. This method showed to be rapid, simple, precise, accurate and economical for determination of nevirapine in pharmaceuticals and it is suitable for routine quality control analysis since CE offers benefits in terms of quicker method development and significantly reduced operating costs.

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Simultaneous determination of lamivudine, stavudine and nevirapine in antiretroviral fixed dose combinations by high performance liquid chromatography

Cited by 34 publications

References 9 publications

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

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

Comparative Application of PLS and PCR Methods to Simultaneous Quantitative Estimation and Simultaneous Dissolution Test of Zidovudine - Lamivudine Tablets

Development and validation of a simple and rapid capillary zone electrophoresis method for determination of nnrti nevirapine in pharmaceutical formulations

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