Strategies For HPLC Method Development And Validation For Pharmaceutical Products Containing Several Active Ingredients

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Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. This presentation will discuss various strategies for the development and validation of HPLC methods with UV detection for drug products containing more than one active ingredient.

OBJECTIVES

• Present typical challenges encountered while developing and validating methods for pharmaceutical products containing more than one active ingredient.

• Provide the analytical chemist with a list of key points to consider while developing and validating analytical methods for pharmaceutical products that contain more than one active ingredient.

• Provide rationale for the proposed strategies using selected monographs listed in the current United States Pharmacopeia for combination products.

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