Strategies for HPLC method development and validation for pharmaceutical products containing several active ingredients
by AAI Pharma Inc.
This white paper by AAI Development Services discusses various strategies for the development and validation of high performance liquid chromatography (HPLC) methods with ultraviolet detection for drug products containing more than one active ingredient by using information from two case studies. This paper describes the typical challenges with combination products, offers key points to consider in developing and validating analytical methods, and provides rationale for the proposed strategies. This paper notes that if one method is being developed for all actives, the diversity in the chromatographic properties between the different actives will most likely require use of a gradient method. Also, if one method is being developed, different wavelengths may be used for each active and its related substances.
| Published: | 2005 |
| Format: | |
| Length: | 24 pages |
| Type: | White paper |
| Language: | English |
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