Quality assessment and Analytical Quality by Design-based RP-HPLC method development for quantification of Piperine in Piper nigrum L.

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Abstract
Background: Piper nigrum L. is one of the widely used herbs in Ayurvedic medicine. Piperine is a major phytoconstituent that is responsible for most of the activity of the herb. Quality assessment and standardization of such phytoconstituents is the need of the hour. The present study aims at developing a Quality by design (QbD)-based RP-HPLC Method for marker-based standardization of Piper nigrum L. fruits along with its quality assessment. Results: The quality assessment of the crude sample was carried out by evaluating pharmacognostic parameters and analysis of toxic contaminants. The analytical target profile and critical quality attributes were determined and 22 factorial design was employed for optimization of the method. By performing the experiments as per the QbD concept the optimized mobile phase was identified as Acetonitrile and Water with 0.05% Acetic acid in the ratio of 70:30, with a flow rate of 1 mL/min and UV detection at 342 nm. The retention time of Piperine was found to be 5.5 min and the amount of Piperine in crude P. nigrum fruits and its extract was found to be 3.6% w/w 5.62% w/w, respectively. The Pharmacognostic parameters showed the results within specified limits and the crude drug sample showed the absence of toxic contaminants in it thus indicating the purity of the drug. Conclusion: The utilization of the QbD approach leads to the development of a more precise and reliable method for the quantification of phytocompounds.

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