Abstract
BackgroundPiper 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.ResultsThe 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.ConclusionThe utilization of the QbD approach leads to the development of a more precise and reliable method for the quantification of phytocompounds.
Highlights
Piper nigrum L. is one of the widely used herbs in Ayurvedic medicine
Quality assessment of P. nigrum fruits Quality assessment of herbal drugs is one of the most essential and crucial tasks which enables the determination of quality and safety of the crude drug
From the established method operable design region (MODR) the optimized chromatographic conditions were predicted based on the specified target or goals of each critical quality attributes (CQA) in terms of overlay plot
Summary
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. Since quality control and standardization of herbal drugs is an important task with great challenges; factors such as geographic and environmental differences of growing conditions, physical constants, adulterations, Chemical marker-based standardization is a widely accepted method for the quality control of herbal drugs. In these methods, suitable markers or pharmacologically active compounds in the herb are analyzed by various chromatographic techniques for evaluating the quality and authenticity of herbal medicines. Along with the utilization of marker-based techniques, the application of novel quality approaches are essential for quality assessment and development standardization parameters for herbal drugs. According to the recent literature the QbD concept can serve as a novel approach for quality control of herbal drugs [7,8,9]
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