Development and validation of a liquid chromatographic method for the determination of amlodipine residues on manufacturing equipment surfaces

Klinkenberg, Régis; Streel, Bruno; Ceccato, Attilio

doi:10.1016/s0731-7085(03)00109-2

Cited by 57 publications

(34 citation statements)

References 21 publications

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“…Therefore, the development and validation of the modified analytical method for the concomitant assay of amlodipine and atenolol consumed considerable time of the research. The methods described in the literature for the determination of amlodipine and atenolol (11,12,15,16) were, in our conditions, found to be unsuitable regarding the resolution of components, large tailing factors and inconsistency. We based our method on the conditions described by Klinkenberg et al (11) but we had to adjust the mobile phase composition.…”

Section: Resultsmentioning

confidence: 64%

“…However, data on the stability of such products are not disclosed and remain mostly with the manufacturer. As the combination of amlodipine and atenolol is not official in the therapeutic Compendia, quantitative analyses of amlodipine (6,11,12) and atenolol (13,14) in pharmaceutical dosage forms are generally described by UV spectrophotometric and high performance liquid chromatographic techniques. Determination of both components in multi-drug tablets is done by various methods such as UV spectrophotometry, HPLC, and HPTLC (15,16).…”

Section: Resultsmentioning

confidence: 99%

“…The method was validated through injection repeatability, linearity tests, recovery test, LOD, LOQ, and accuracy (11). In the injection repeatability test, the relative standard deviations (RSD) of the peak area of six consecutive injections were found to be 0.8 and 0.7% for atenolol and amlodipine, respectively.…”

Section: Validation Of the Hplc Methodsmentioning

confidence: 99%

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Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Aryal¹,

Škalko‐Basnet²

2008

Acta Pharmaceutica

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Fixed-dose drug combination decreases the risk of patient non-compliance and should be considered in patients with chronic conditions like hypertension (1). Clinically, combination therapy in hypertension treatment involving two or more drugs from different classes can result in better drug efficacy and is recommended for the initial stage of hypertension treatment (2). The combination of atenolol and amlodipine significantly decreases blood pressure and systolic blood pressure variability. In spontaneously hypertensive rats, the synergistic effect between atenolol and amlodipine results in lowering and stabilizing of blood pressure (3). Both beta blockers and dihydropyridine calcium antagonist are widely used in the treatment of hypertension. Their combination is a logical choice and can also neutralize the side effects of each drug. Combination therapy is likely to be the optimal way to control blood pressure and reduce blood pressure Multi-drug tablets of amlodipine besylate and atenolol were prepared as either mono-layer (mixed matrix) or bi--layer tablets containing each drug in a separate layer by using similar excipients and processing. Each tablet batch was packed in strip and blister packs and kept under accelerated temperature and humidity conditions. The stability of two tablet and packaging types was compared by HPLC analysis after 0, 1, 3 and 4.5 months and expressed as the content of intact amlodipine and atenolol. The content of atenolol did not decline regardless of tablet and packaging type. Amlodipine content in bi-layer tablets decreased to about 95 and 88% when packed in strips and blisters, respectively. When prepared as mono-layer tablets, the content decreased to 72 and 32%, respectively. The study revealed that the bi-layer tablet formulation was more stable than the mono-layer type. Further, the stability was increased when the tablets were packed in aluminium strips as compared to PVC blisters.

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Section: Resultsmentioning

confidence: 64%

Section: Resultsmentioning

confidence: 99%

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Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Aryal¹,

Škalko‐Basnet²

2008

Acta Pharmaceutica

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“…A maioria destes aplicou técnicas cromatográficas, dentre elas CLAE, [8][9][10][11][12][13] cromatografia líquida de ultra eficiência (CLUE), 14 cromatografia líquida acoplada à espectrometria de massas 15 e cromatografia eletrocinética micelar (MEKC), 16 para determinar resíduos de princípios ativos farmacêuticos, tais como anlodipina, 8 azatioprina, 9 lacidipina, 10 derivados cortisônicos, 11 lamivudina e zidovudina, 12 pirimetamina e sulfadoxina, 13 compostos esteroidais, 14 cefmetazol e cefpodoxima proxetil, 15 e cotrimetoxazol. 16 Na presente aplicação, a associação entre sulfametoxazol (SMX) e trimetoprima (TMP) foi selecionada para a validação de limpeza de um equipamento de produção.…”

Section: Introductionunclassified

Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção

Coutinho¹,

Barbosa²,

Sena³

et al. 2009

Quím. Nova

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Recebido em 22/1/09; aceito em 28/4/09; publicado na web em 30/9/09 SIMULTANEOUS DETERMINATION OF SULFAMETHOXAZOLE AND TRIMETHOPRIM RESIDUES ON MANUFACTURING EQUIPMENT SURFACES. A cleaning validation method was developed and validated, based on swabbing sampling and simultaneous chromatographic determination of sulfamethoxazole (SMX) and trimethoprim (TMP) residues. The method presented limits of detection of 0.06 mg mL -1 for SMX and 0.09 mg mL -1 for TMP. It was considered selective, precise, accurate and robust according to the guidelines from ANVISA, the Brazilian regulatory agency, and International Conference on Harmonization. Mean swab recovery factors of 98.5% for SMX and 97.7% for TMP were obtained for spiked stainless steel plates. The method was successfully applied to the assay of actual swab samples collected from eleven points on an equipment surface.Keywords: HPLC; cleaning validation; swabbing recovery. INTRODUÇÃOO primeiro caso de contaminação cruzada na indústria farmacêutica relatado na literatura científica ocorreu nos anos 60, quando graves e inesperados efeitos colaterais foram observados devido à contaminação de isoniazida (hidrazida do ácido isonicotínico) com dietilestilbestrol.1 Nos últimos anos, vários produtos farmacêuticos foram retirados do mercado devido à contaminação cruzada com outros princípios ativos ou substâncias químicas.2 Em consequência disto, a validação de limpeza tornou-se um aspecto crítico a ser enfrentado pela indústria farmacêutica. O seu objetivo é provar, através de um método analítico validado e suficientemente sensível, que o procedimento de limpeza de equipamentos e superfícies é eficiente na remoção de resíduos de princípios ativos, excipientes, produtos de degradação, substâncias usadas na limpeza e outros possíveis contaminantes, reduzindo assim o risco de contaminação cruzada na área de produção. Desse modo, é necessário tanto assegurar que os contaminantes sejam removidos do equipamento, quanto determinar o nível de consistência dessa remoção. Este assunto é parte integrante do conjunto de normas que compõem as boas práticas de fabricação (BPF) e a validação de limpeza deve seguir as resoluções dos organismos reguladores. [3][4][5] Como os equipamentos são usados na produção de diversas formulações farmacêuticas, costuma-se definir um cenário de pior caso.6,7 Um produto de referência é escolhido como o pior caso para a validação de limpeza, levando em conta variáveis relacionadas à sua toxicidade e dificuldade de limpeza. Uma vez que o produto considerado o pior caso tenha sido escolhido, surge um outro aspecto importante que é a amostragem. Para isso, dois métodos são indicados:5 a amostragem direta da superfície, usando a técnica de swabbing (escovação) e, a amostragem indireta, baseada na análise das soluções usadas para enxaguar o equipamento. Na maior parte da literatura, a técnica de swabbing é a preferida, porque permite que resíduos secos e/ou insolúveis sejam mais eficientemente amostrados por remoção física e torna possível avaliar as áreas do e...

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“…[7][8][9] As analytical methods for the determination of pharmaceutical residues at manufacturing facilities, the HPLC-UV method [10][11][12][13] and total organic carbon (TOC) method 14) have generally been used. However, in spite of universal application of these methods for detection of pharmaceutical residues, their application to monitoring of trace amounts of residues or contaminants of highly potent or sensitizing pharmaceuticals is limited due to their lack of selectivity and sensitivity.…”

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confidence: 99%

Verification of Cefmetazole and Cefpodoxime Proxetil Contamination to Other Pharmaceuticals by Liquid Chromatography-Tandem Mass Spectrometry

Fukutsu¹,

Sakamaki²,

Ḱawasaki³

et al. 2006

CHEMICAL & PHARMACEUTICAL BULLETIN

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Development and validation of a liquid chromatographic method for the determination of amlodipine residues on manufacturing equipment surfaces

Cited by 57 publications

References 21 publications

Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção

Verification of Cefmetazole and Cefpodoxime Proxetil Contamination to Other Pharmaceuticals by Liquid Chromatography-Tandem Mass Spectrometry

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