Development and validation of a dissolution test for telithromycin in coated tablets

Vaucher, Lauren Rosa Crossetti; Paim, Clésio Soldateli; Lange, Alini Dall Cortivo; Schapoval, Elfrides Eva Scherman

doi:10.1590/s0100-40422009000500041

Cited by 14 publications

(18 citation statements)

References 11 publications

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“…issolution testing is considered as an important tool to evaluate the performance of oral solid dosage forms, and more stress is given to dissolution testing by pharmaceutical industries and regulatory authorities (1)(2)(3)(4)(5)(6). Dissolution tests can detect variation in lot-to-lot quality of a drug product during formulation stages and after changes in the manufacturing process (2,3).…”

mentioning

confidence: 99%

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Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Shaikh¹,

Patel²,

Patel³

et al. 2018

Dissolution Technol.

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Lercanidipine hydrochloride (HCl) is L-type calcium channel blocker widely used in the management of hypertension. According to the BCS classification system, it is classified under BCS class II drugs, showing low solubility and high permeability. The dissolution profile and thus the in vivo performance of this class of drugs widely depend on their solubility and hence their behaviour in dissolution medium. Lercanidipine HCl is not official in any pharmacopeia, so no official dissolution method is available. The present work is mainly focussed on development and validation of a dissolution test that can be used as a quality control test for lercanidipine HCl tablets and formulations. Saturation solubility and sink conditions that can be achieved in different media suggested that 0.1 N HCl, acetate buffer pH 4.5, and phosphate buffer pH 6.8 can be used as a dissolution medium. Dissolution tests of lercanidipine HCl tablets were carried out in these different media at different rotation speeds using a USP type II (paddle) apparatus. The most suitable dissolution conditions were 0.1 N HCl pH 1.2 (900 mL at 37 ± 0.5 °C) as a dissolution medium and a paddle apparatus at 100 rpm for 60 min. The analysis of released lercanidipine HCl was done by ultraviolet spectrophotometry. The developed method was validated according to ICH guidelines. This method showed linearity with an r 2 value of 0.999 within the concentration range of 2-20 µg/mL. The method was found to be accurate with recoveries ranging from 98.50% to 103.72%. The interday and intraday precision was below RSD 2%. The developed method can effectively be used for quality control evaluation of lercanidipine HCl tablets.

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mentioning

confidence: 99%

“…Dissolution tests can detect variation in lot-to-lot quality of a drug product during formulation stages and after changes in the manufacturing process (2,3). It is one of the important quality control tests used to assure product uniformity and batch-to-batch bioequivalence (7).…”

mentioning

confidence: 99%

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Shaikh¹,

Patel²,

Patel³

et al. 2018

Dissolution Technol.

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“…From a biopharmaceutics point of view, a more 424 discriminating dissolution method is preferred because the test will indicate possible changes in product quality (Vaucher, 2009).…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension

Rubim

Rubenick

Laporta

et al. 2014

Braz. J. Pharm. Sci.

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The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium. O presente estudo descreve o desenvolvimento e validação de um método de dissolução in vitro para avaliação da liberação de diclofenaco potássico suspensão oral. O teste de dissolução foi desenvolvido e validado de acordo com as diretrizes internacionais. Parâmetros como linearidade, especificidade, precisão e exatidão foram avaliados, bem como a influência da velocidade de rotação e a concentração de tensoativono meio. Depois de selecionar as melhores condições, o método foi validado usando o aparato 2 (pás), velocidade de rotação de 50 rpm, 900 mL de água com 0,3% de lauril sulfato de sódio (LSS) como meio de dissolução a 37,0 ± 0,5 ºC. As amostras foram analisadas pelo método de CLAE-UV (PDA). Os resultados obtidos foram satisfatórios para os parâmetros avaliados. O método desenvolvido pode ser útil na rotina de controle de qualidade para as indústrias farmacêuticas que produzem suspensões orais contendo diclofenaco potássico. Unitermos: Método de dissolução/desenvolvimento. Método de dissolução/validação. Diclofenaco potássico/liberação em suspensão oral. Suspensão oral/controle de qualidade. Cromatografia líquida de alta eficiência/análise qualitativa.

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“…For these reasons, progressively more emphasis has been placed on dissolution testing within the pharmaceutical industry and by regulatory authorities (2).…”

Section: Introductionmentioning

confidence: 99%

A Dissolution Test for Finasteride in Immediate-Release Capsules

Santos¹,

Santos²,

Pereira³

et al. 2013

Dissolution Technol.

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In vitro dissolution tests for solid oral dosage forms are extremely important to ensure the quality of these products. However, no dissolution test has been reported for finasteride (FNS) in immediate-release capsules. The aims of this work were to optimize a dissolution method for FNS capsules, validate the analytical method, and evaluate three different commercial products. The best in vitro dissolution profile was achieved using water as the dissolution medium with a basket stirrer at 100 rpm. The quantitative determination was performed by high performance liquid chromatography (HPLC) at 210 nm. All validation parameters were satisfactory. The application of the method to commercial products showed the discriminatory power of the dissolution method. Because there is no monograph for FNS in capsules, this study illustrates the importance of an official dissolution test for FNS in capsules and the need to standardize the composition of the excipients contained in these commercial products.

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Development and validation of a dissolution test for telithromycin in coated tablets

Cited by 14 publications

References 11 publications

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension

A Dissolution Test for Finasteride in Immediate-Release Capsules

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