Validation of Dietary Supplements. Process Validation

      Аннотация: An RP-HPLC method was developed and validated for simultaneous estimation of active marker components of Boswellia serrata extract containing Boswellic acids (KBA and AKBA), Withania somnifera extract containing Withaferin A and Cissus quadrangularis extract containing Stigmasterol in their combined dosage form as Tablet or capsule or powder blend. RP-HPLC method was developed and validated; and successfully applicable for estimation of desired components from the formulation. Prospective process validation was conducted for tablet manufacturing process of LCOX tablet containing the above mentioned three components. Quality control testing for tablets was performed and compared for three consecutive batches of the stated formulation. Various critical control parameters for each processing step (Blending, Compression, Coating, Blister pack) were identified and evaluated as per the designed process validation protocol. Validation studies reveal that there is no significant variation in the quality of finished product of all three batches manufactured using same batch size on same equipments, under similar environmental conditions.

Ключевые слова: HPLC, validation, stigmasterol, AKBA, KBA, Withaferin A