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.

Keywords: Quality by design (QbD), Piper longum (Pipali), ayurvedic, herbal drug, RP-HPLC method, chromatographic method development.