Answer:
Establishing a pharmaceutical analysis method for biological samples can present a range of challenges. According to the search results, some of the challenges include the complexity of the biological matrix, which can make it difficult to extract and detect the target analyte, as well as the need for effective sample preparation to reduce interference and increase sensitivity. Other challenges include the lack of universal chiral columns , the need to demonstrate the accuracy, precision, and selectivity of the method, and the need to establish acceptance criteria for that drug product. Additionally, the search results suggest that the development of analytical procedures and validation methods must follow guidelines for the industry and be demonstrated by analyzing blank samples of the appropriate biological matrix
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