Low level drug product API form analysis - Avalide tablet NIR quantitative method development and robustness challenges
| Autor: | Shawn X. Yin, Duohai Pan, George Crull, John A. Grosso |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Chemistry
Pharmaceutical Clinical Biochemistry Analytical chemistry Pharmaceutical Science Form analysis Tetrazoles Analytical Chemistry Granulation Irbesartan Robustness (computer science) Limit of Detection Drug Discovery medicine Particle Size Spectroscopy Detection limit Active ingredient Chromatography Spectroscopy Near-Infrared Chemistry Biphenyl Compounds Humidity Method development Hydrochlorothiazide Drug product medicine.drug Tablets |
| Zdroj: | Journal of pharmaceutical and biomedical analysis. 89 |
| ISSN: | 1873-264X |
| Popis: | Avalide(@), a medication used for the treatment of hypertension, is a combination of Irbesartan, and Hydrochlorothiazide. Irbesartan, one of the active pharmaceutical ingredients (API) in Avalide products, exists in two neat crystalline forms: Form A and Form B. Irbesartan Form A is the API form used in a wet granulation for the preparation of Avalide tablets. The presence of the less soluble Irbesartan Form B in Avalide tablets may result in the slower dissolution. In this paper, we have presented our work on the method development, verification and challenges of quantitatively detecting, via NIR and ssNMR, very small amounts of Irbesartan Form B in Avalide tablets. As part of the NIR method development and qualification, limit of detection, linearity and accuracy were examined. In addition, a limited study of the robustness of the method was conducted and a bias in the level of Form B was correlated to the ambient humidity. ssNMR, a primary method for the determination of polymorphic composition, was successfully used as an orthogonal technique to verify the accuracy of the NIR method and added to the confidence in the NIR method. The speed and efficiency of the NIR method make it a suitable and convenient tool for routine analysis of Avalide tablets for Form B in a QC environment. |
| Databáze: | OpenAIRE |
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