Simultaneous determination of binary mixtures of trimethoprim and sulfamethoxazole or sulphamethoxypyridazine by the bivariate calibration spectrophotometric method

López-Martínez, Leticia X.; López-de-Alba, Pedro Luı́s; de-León-Rodrı́guez, Luis Manuel; Yepez-Murrieta, Ma Lourdes

doi:10.1016/s0731-7085(02)00133-4

Cited by 40 publications

(20 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The effect of pH on the absorption spectra of SMX and TMP were studied previously at the corresponding maximum absorption wavelength and a value of pH 10.0 were selected based on sensitivity and stability of the analytes 16 . The absorption spectra of SMX and TMP are shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

“…Liquid chromatography 10,12 and gas chromatography 13 have also been proposed for its individual determination or together with its major metabolites of oxidation in different matrices. The simultaneous determination of both analytes has been usually carried out by spectrophotometric methods with multi component analysis based on the use of second derivative and diode-array detection 14 , first derivative and spectra ratio 15 , bivariate calibration spectrophotometrics 16 , high-performance liquid chromatography (HPLC) 17 . However, these methods are generally complex in nature and need expensive instruments and ultra pure solvents.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Direct Orthogonal Signal Correction-Partial Least Squares for Simultaneous Spectrophotometric Determination of Sulfamethoxazole and Trimethoprim in Pharmaceutical Formulation and Synthetic Samples

Goodarzi

Shahbazikhah

Sohrabi

et al. 2009

J. Chil. Chem. Soc.

View full text Add to dashboard Cite

This work describes a very simple, novel and selective spectrophotmetric method for simultaneous determination of sulfamethoxazole and trimethoprim in pharmaceutical preparation and synthetics samples using direct orthogonal signal correction-partial least squares (DOSC-PLS). The all factors affecting on the sensitivity were optimized and the linear dynamic range for determining of these drugs was found. The PLS modeling was used for the multivariate calibration of the spectrophotometric data and DOSC was used for preprocessing of data matrices and the prediction results of model. The experimental calibration matrix was designed by measuring the absorbance over the range 200-400 nm for 32 samples of 2.0-15.0 and 0.4-6.0 μg mL -1 of sulfamethoxazole and trimethoprim, respectively. The root mean square error of prediction for sulfamethoxazole and trimethoprim using DOSC-PLS and PLS were 0.02212, 0.02363 and 0.17014, 0.01660,μg mL -1 respectively. Application of the method to synthetic samples of standard solutions and in pharmaceutical formulation was performed and satisfactory results were obtained.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Direct Orthogonal Signal Correction-Partial Least Squares for Simultaneous Spectrophotometric Determination of Sulfamethoxazole and Trimethoprim in Pharmaceutical Formulation and Synthetic Samples

Goodarzi

Shahbazikhah

Sohrabi

et al. 2009

J. Chil. Chem. Soc.

View full text Add to dashboard Cite

show abstract

“…25,26 O objetivo deste trabalho foi desenvolver e validar um método analítico para a validação de limpeza das superfícies de um equipamento de produção farmacêutica, através da determinação cromatográfica simultânea de resíduos de SMX e TMP e usando a técnica de swabbing para amostragem. Ao invés de usar metanol, como na maioria dos trabalhos com swabbing, optou-se por um solvente menos tóxico, uma mistura etanol-água.…”

Section: Introductionunclassified

“…19 Os métodos encontrados na literatura para a determinação simultânea de SMX e TMP em formulações farmacêuticas são baseados em CLAE, [20][21][22] eletroforese capilar 23,24 e espectrofotometria com detecção multivariada. 25,26 O objetivo deste trabalho foi desenvolver e validar um método analítico para a validação de limpeza das superfícies de um equipamento de produção farmacêutica, através da determinação cromatográfica simultânea de resíduos de SMX e TMP e usando a técnica de swabbing para amostragem. Ao invés de usar metanol, como na maioria dos trabalhos com swabbing, optou-se por um solvente menos tóxico, uma mistura etanol-água.…”

Section: Introductionunclassified

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

Coutinho¹,

Barbosa²,

Sena³

et al. 2009

Quím. Nova

View full text Add to dashboard Cite

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...

show abstract

“…[7][8][9] The modification of this method was the first time applied to the analysis of ternary mixtures 10) and called as tri linear regression analysis (TLRC). This method also further modified the same method for the three and more component mixtures and called as multi linear regression analysis (MLRC).…”

mentioning

confidence: 99%

Mathematical Algorithms Applied to the Multi-linear Regression Functions for the Multicomponent Determination of Pharmaceutical Dosage Form Containing Three-component Mixtures

Dinç

Özdemir

2005

CHEMICAL & PHARMACEUTICAL BULLETIN

View full text Add to dashboard Cite

Applied methods for the analytical problems have considerable importance in the rapidity, reliability and cost of method for the quantitative analysis of compounds. Most of the new method developments and instrumental advances are focus on the less time and money consumption. In pharmaceutical science the quantitation of the compounds in the mixtures has a big importance and there are several techniques for the quantitation of those compounds including as a well known technique HPLC, derivative spectrophotometry and chemometric techniques. Advances in spectrophotometric methods with various mathematical algorithms allow to a wide application of UV absorption in the drug analysis, biological sample analysis and environmental analysis. Spectrophotometric methods are a rapid and cheap method and suitable for the analysis of raw materials and finished products without sample preparation by the combination of numerical methods using software. Hence, applications of other analytical methods such as dual wavelength spectrophotometry, 1-3) pH-induced differential spectrophotometry 4) and multi-component analysis method aided computer software 5,6) can be given as an example for the analytical studies. All the motioned methods give good results, but they contain some disadvantage in the application to the analytical problems. For example HPLC is a laborious method that requires development of an acceptable method for separation and sometimes it is not possible to resolve the mixture of compounds, and some others contain abstract mathematical knowledge to understand the theory behind it. On the other hand while derivative spectrophotometry provides good results for the resolution of binary mixtures, it has not given successful results in the analysis of ternary or multi-mixtures.Analytical chemists have been forcing the limit of every applicable mathematical methods ranging from very abstract to a simple one to apply them to solve the analytical problems. The simplest method will make the life easier and will provide faster analysis of compounds.In recent years the simultaneous analysis of binary mixtures using a numerical method has been carried out.7-9) The modification of this method was the first time applied to the analysis of ternary mixtures 10) and called as tri linear regression analysis (TLRC). This method also further modified the same method for the three and more component mixtures and called as multi linear regression analysis (MLRC). While TLRC method based on the finding of the best three wavelengths in the spectrum, MLRC method contains multi critical wavelength points in the working wavelength range and both use the linear algebra for matrix form obtained from the linear regression functions.The quantitation of PAR, ASP and CAF in the same ternary mixture has been done using N-PLS chemometric method 11) but this method contains various disadvantage including complex and abstract mathematical treatments and special software. The proposed TLRC and MLRC models are very powerful tools having the simple mathe...

show abstract

Simultaneous determination of binary mixtures of trimethoprim and sulfamethoxazole or sulphamethoxypyridazine by the bivariate calibration spectrophotometric method

Cited by 40 publications

References 23 publications

Direct Orthogonal Signal Correction-Partial Least Squares for Simultaneous Spectrophotometric Determination of Sulfamethoxazole and Trimethoprim in Pharmaceutical Formulation and Synthetic Samples

Direct Orthogonal Signal Correction-Partial Least Squares for Simultaneous Spectrophotometric Determination of Sulfamethoxazole and Trimethoprim in Pharmaceutical Formulation and Synthetic Samples

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

Mathematical Algorithms Applied to the Multi-linear Regression Functions for the Multicomponent Determination of Pharmaceutical Dosage Form Containing Three-component Mixtures

Contact Info

Product

Resources

About