Simultaneous determination of lamivudine and stavudine in antiretroviral fixed dose combinations by first derivative spectrophotometry and high performance liquid chromatography

Kapoor, Namita; Khandavilli, Sateesh; Panchagnula, Ramesh

doi:10.1016/j.jpba.2006.01.007

Cited by 38 publications

(22 citation statements)

References 7 publications

(9 reference statements)

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“…Three different buffer solutions (pH 1.2, 4.5, 6.8) and deaerated water (10) were used as the dissolution media (900 mL), and the paddle rotation speed was kept at 50 rpm. In all experiments, 2-mL samples were withdrawn at predetermined time intervals (5,10,15,20,25,30,40,50, and 60 min) and replaced with an equal volume of fresh medium to maintain a constant total volume. After filtration, the concentrations of lamivudine in samples were determined by a validated HPLC method.…”

Section: Dissolution Media and Test Apparatusmentioning

confidence: 99%

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Öztürk¹,

Kaynak²,

Şahin³

2015

Dissolution Technol.

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The aim of this study was to investigate the influence of dissolution medium on the in vitro release of lamivudine (100 mg) from four commercially available lamivudine tablets (one reference and three generic). Three different buffer solutions (pH 1.2, 4.5, 6.8) and deaerated water were used as the dissolution media (900 mL), and the paddle rotation speed was kept at 50 rpm with twelve replicates. An RP-HPLC method was developed for analysis of lamivudine in samples obtained from dissolution studies. The mobile phase consisted of acetonitrile/water (10:90) pH adjusted to pH 2.5 with o-phosphoric acid, a C 18 column (Ace 250 × 4.60 mm, 5 µm) was used, and the flow rate was set at 1 mL/min. All the drugs tested were very rapidly dissolving (more than 85% of the labeled amount in 15 min), and the dissolution profiles of the generic tablets were thus considered similar to that of the reference tablet in each of the buffers at pH 1.2, 4.5, and 6.8, and deaerated water. Because of the dissolution results and the high solubility and borderline permeability, a biowaiver can be proposed for lamivudine immediate-release solid oral dosage forms provided that the excipient composition of the test product is the same as or similar to that of the reference product and the excipients that have an effect on bioavailability are qualitatively and quantitatively the same as that of the reference product.

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Section: Dissolution Media and Test Apparatusmentioning

confidence: 99%

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Öztürk¹,

Kaynak²,

Şahin³

2015

Dissolution Technol.

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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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“…Kapoor et al have employed derivative spectrometry for the simultaneous determination of Estavudina (d4T) e lamivudine (3TC) antiretroviral in fixed dose combinations. 23 Multivariate calibration has also been used to solve the problems of overlapping Uv spectra in mixtures of two or more components and when there is interference from the formulation matrix. [24][25][26][27][28] Inverse calibration methods such as Partial Least Square (PLS) are widely used.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous spectrophotometric determination of lamivudine and zidovudine in fixed dose combinations using multivariate calibration

Grangeiro¹,

Albuquerque²,

Santana³

et al. 2011

Quím. Nova

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Recebido em 12/3/10; aceito em 17/11/10; publicado na web em 25/2/11The simultaneous determination of two or more active components in pharmaceutical preparations, without previous chemical separation, is a common analytical problem. Published works describe the determination of AZT and 3TC separately, as raw material or in different pharmaceutical preparations. In this work, a method using UV spectroscopy and multivariate calibration is described for the simultaneous measurement of 3TC and AZT in fixed dose combinations. The methodology was validated and applied to determine the AZT+3TC contents in tablets from five different manufacturers, as well as their dissolution profile. The results obtained employing the proposed methodology was similar to methods using first derivative technique and HPLC.

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Simultaneous determination of lamivudine and stavudine in antiretroviral fixed dose combinations by first derivative spectrophotometry and high performance liquid chromatography

Cited by 38 publications

References 7 publications

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

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

Simultaneous spectrophotometric determination of lamivudine and zidovudine in fixed dose combinations using multivariate calibration

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