The multicomponent automated dissolution system: an alternative in the development and pharmaceutical analysis of generic polydrugs.
The necessity of assuring the quality of polydrugs, especially those with low aqueous solubility and in vivo absorption, has led to the development and evaluation of new techniques that can reduce the time and cost of analysis. This study examines the efficiency and accuracy of an automated dissolution system, fitted with an integrated multicomponent detector, for analysis of generic polydrugs using multiple linear regression (MLR). Trimethoprim and sulphamethoxazole were chosen as model drugs for this study and comparison was made with a conventional analysis based on HPLC. Both analytical systems under study gave reproducible and accurate results. Analysis of variance showed that there was no significant statistical difference between the methods of analysis, nor any statistical difference between the measured amounts of drug in the three different formulations. We have demonstrated that low cost instrumentation coupled with MLR data processing provides entirely satisfactory drug analysis to standard at least as good as that achieved using HPLC and provides an opportunity to reduce the time and analysis cost of other generic formulations.
Fuerte
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Centro de Investigacion y de Estudios Avanzados del IPN, Antiguo Camino a Xochimilco, Tepepan, Mexico City, Mexico.
Maldonado
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M
Rees
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GD
D001331:Automation; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D016568:Drugs, Generic / Q000032:analysis* / Q000191:economics; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D012044:Regression Analysis; D015203:Reproducibility of Results; D012996:Solutions; D013053:Spectrophotometry / Q000379:methods; D013420:Sulfamethoxazole / Q000032:analysis; D013607:Tablets / Q000032:analysis; D013997:Time Factors; D014295:Trimethoprim / Q000032:analysis
D004338:Drug Combinations; D016568:Drugs, Generic; D004364:Pharmaceutical Preparations; D012996:Solutions; D013607:Tablets; D014295:Trimethoprim; D013420:Sulfamethoxazole