Title:Scientific Validation and Chromatographic Method Development for the Estimation of Piperine in Herbal Formulation Babbularishta: A Quality Control Strategy for Critical Quality Attributes
Volume: 21
Issue: 4
Author(s): Bina Gidwani, Gunjan Kalyani, Ravindra Kumar Pandey and Shiv Shankar Shukla*
Affiliation:
- Department of Pharmaceutical Quality Assurance, Columbia Institute of Pharmacy, Tekari Raipur, C.G., India
Keywords:
Quality by design (QbD), Piper longum (Pipali), ayurvedic, herbal drug, RP-HPLC method, chromatographic method development.
Abstract:
Background: Babbularishta is an Ayurvedic medicine in liquid form used for the
treatment of phthisis, skin diseases, urinary disorders, and breathing problems. It is also beneficial
in cases of blood disorders, acne, dermatitis, hemoptysis, lung injury, asthma, persistent
cough, whooping cough, etc.
Objective: The functional role of this study is to develop a simple, novel, precise, accurate, reliable,
and selective RP-HPLC method for the estimation of piperine content in herbal drug formulations
(Babbularista).
Methods: A traditional approach to method development could fail to meet the desired separation.
Consideration of the current regulatory requirement for analytical method development
and RP-HPLC method for routine analysis of piperine in the herbal formulation has been optimized
using an analytical Quality by Design (QbD) approach. Three laboratory formulations
and three marketed preparations of Babularishta were investigated for organoleptic parameters,
physicochemical parameters, and validation. The mobile phase composition (methanol and water
% as A), pH (B), and flow rate (mL/min as C) were selected as independent variable. In
contrast, retention time (min. as Y2), area (AU as Y1) is selected as dependent variables.
Results: The fingerprinting method was developed and optimized by using the AQbD approach.
Piperine content was found to be in Piper nigrum (Marica) 3.01 ± 0.01527% w/w and
in Piper longum (Pipali) 2.74 ± 0.01154% w/w in Babbularista.
Conclusion: An attempt has been made to develop quality control parameters of Babbularista
by developing a suitable and sensitive HPLC methods for the quantitation of piperine in herbal
drug formulations (Babbularista). The developed method was found to be simple, accurate, precise,
and economical for the estimation of piperine in herbal formulations.
Highlights: The novelty of the current research work lies in developing and optimizing the RPHPLC
method by the AQbD approach for the estimation of piperine content in herbal formulations,
Babbularista.
