Abstract

DEVELOPMENT OF METHOD FOR EXTRACTION AND VALIDATION CRUDE DRUGS FROM PLANT EXTRACT

Apurva Darwai*, Neelam Jain

Department of Pharmaceutics, Faculty of Pharmacy, Oriental University, Indore-453555, Madhya Pradesh, India

ABSTRACT

This research is focused on development of a modified, simple, accurate, and economical HPLC method for quantitative determination of selected herbal drugs. Use of herbal drug for the treatment of various diseases have intensively increasing due to its economical nature as well as less side effects as compared those seen in other conventional medications. With increasing use of these drugs, a define method is been required for standardization of these Polyherbal medication to maintain its quality, safety, and efficacy. Method development for proper standardization of various phytochemical analysis along with HPLC method development was conducted to analyse the extract obtained for the plant. Method validation was conducted by analysing the method for its linearity, recovery, method and system precision, limit of detection (LOD), limit of quantification (LOQ) and robustness in accordance with ICH guidelines Q2 (R1). Percentage purity of the extract obtained was found to be 98% with presence of 23.86 mg of extract. Linearity study followed a range of 2 - 12 μg/ml with correlation coefficient 0.9996. Precision study conducted for both inter-day and intra-day depicted a % RSD of 0.56% and 0.171% respectively indicating that the proposed method was more accurate than the existing methods. The LOD and LOQ value for Piperine was found to be 0.126 µg/ml, 0.384 µg/ml, respectively. Thus resembles that the proposed method was sensitive.

Keywords: Validation, Precision, Polyherbal Formulation, Precision, Accuracy, LOD, LOQ.