Validação de metodologia para doseamento e estudo de equivalência farmacêutica de comprimidos de lamivudina 150 mg

Fernandes, Christian; Campos, Lígia Maria Moreira de; Pianetti, Gérson Antônio

doi:10.1590/s1516-93322003000400005

Cited by 4 publications

(6 citation statements)

References 3 publications

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“…In contrast to our results regarding quality, Fernandes et al . reported that two generic batches of LMV failed the quality test for dissolution 15 . Later in 2015, Wang et al .…”

Section: Discussionmentioning

confidence: 99%

“…En contraste con los resultados de calidad encontrados en esta investigación, Fernandes et al . informaron que dos lotes genéricos de LMV no cumplieron la prueba de calidad para disolución 15 . Posteriormente en 2015, Wang et al .…”

Section: Discussionunclassified

“…Además, los dos lotes de medicamentos multifuentes A y B demostraron similitud entre los porcentajes de fármaco recuperado con el medicamento innovador, en los tres pH fisiológicos y se observó que a los 15 min el porcentaje de disolución en ambos casos fue mayor del 85%, por lo que no fue necesario calcular el f2. En contraste con los resultados de calidad encontrados en esta investigación, Fernandes et al informaron que dos lotes genéricos de LMV no cumplieron la prueba de calidad para disolución (15) . Posteriormente en 2015, Wang et al reportaron que 6 de 88 muestras (de países en vías de desarrollo y compras por Internet) fallaron la prueba de disolución en 1,5-8,3%, por debajo del rango estándar en un estudio multicéntrico (16) .…”

Section: Discussionunclassified

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Evaluación comparativa de perfiles de disolución del medicamento genérico lamivudina tableta 150 mg comercializado en Perú frente al innovador Epivir

Castañeda-Alarcón,

García-Montoya,

Rodríguez-Calzado

et al. 2024

Rev Peru Med Exp Salud Publica

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Lamivudine is one of the most prescribed drugs in the world, and is used to treat human immunodeficiency and hepatitis B. This study aimed to evaluate the quality attributes and compare the dissolution profiles of two batches (A and B) of generic lamivudine 150 mg tablets with the innovator drug Epivir 150 mg tablets. We conducted an analytical, experimental, cross-sectional study, and used a spectrophotometric method at a wavelength of maximum absorption (λ) corresponding to 270 nm, to measure the percentage of dissolved drug. The study evaluated identification, content, dissolution and mass uniformity. Apparatus 2 USP (Paddle) 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) was used in three dissolution media: pH 1.2; 4.5 and 6.8. Samples of 5 mL were obtained at 5, 10, 15, 20 and 30 min. Both batches of generic lamivudine (A and B) were found to have the same dissolution kinetic profile as the innovator drug. Both formulations met the criteria of very fast dissolving (85% dissolved in 15 min), and fast dissolving (85% dissolved in 30 min) drugs. Therefore, it was not necessary to calculate the similarity factor. We concluded that generic drugs A and B are in vitro equivalents to the innovator drug Epivir.

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“…In contrast to our results regarding quality, Fernandes et al . reported that two generic batches of LMV failed the quality test for dissolution 15 . Later in 2015, Wang et al .…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionunclassified

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Evaluación comparativa de perfiles de disolución del medicamento genérico lamivudina tableta 150 mg comercializado en Perú frente al innovador Epivir

Castañeda-Alarcón,

García-Montoya,

Rodríguez-Calzado

et al. 2024

Rev Peru Med Exp Salud Publica

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“…In the British Pharmacopoeia, the methods provided use ultraviolet spectrophotometry at 280 nm and 266 nm, for lamivudine and zidovudine, respectively (BP, 2018a;2018b). Some published works have reported methods of quantification of lamivudine and zidovudine tablets in dissolution studies through UV spectrophotometric and HPLC (Fernandes et al, 2003;Hwisa et al, 2013;Mandloi et al, 2009;Ozturk et al, 2015;Stuart et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

Development and validation of ultraviolet spectrophotometric methods for lamivudine and zidovudine quantification in dissolution test

Perez-Chauca¹,

Alva-Plasencia²,

Ferraz³

2022

J Pharm Pharmacogn Res

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Context: In the development of a good analytical method, the selection of appropriate conditions for quantifying drugs is essential. The method validation should be determined before conducting the dissolution test. Aims: To develop and validate two analytical methods by UV spectrophotometry to quantify lamivudine and zidovudine in dissolution test. Methods: The dissolution conditions were 900 mL of dissolution medium (pH 1.2, pH 4.5, and pH 6.8), using paddles, at 75 rpm, and sampling time points of 5, 10, 15, 20, and 30 minutes. The analytical methods were developed by scanning analytical solutions in the UV region. The proposed methods were validated in accordance with the ICH guideline and the United States Pharmacopoeia. Results: Lamivudine showed wavelengths at 280 nm, 273 nm, and 270 nm in buffers at pH 1.2, pH 4.5, and pH 6.8, respectively; while zidovudine showed a wavelength at 266 nm in all three buffers. Regression analysis confirmed linearity (r2>0.998). Placebos and diluents showed no analytical interference. LOD and LOQ were lower than the linearity range. Recovery percentages were within 95% to 105%. RSD values were below 2% and 7% for repeatability and intermediate precision, respectively. No changes introduced modified the method response. The analytical solutions were stable until 24 hours. The results showed that Whatman No 41, No 42, and PVDF 0.45 µm filters can be used. Conclusions: The proposed analytical methods demonstrated linearity, specificity, accuracy, and precision. In addition, LOD and LOQ, robustness, stability of the analytical solution, and filter test showed satisfactory results.

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“…Os estudos de equivalência farmacêutica verificam se o medicamento cumpre com os testes farmacopéicos, destacando-se os testes de identificação da substância ativa e dos produtos secundários, verificação do teor do fármaco, da dissolução e do perfil de dissolução (Fernandes, 2001).…”

Section: Introductionunclassified