Development and validation of analytical method of silymarin by RP-HPLC with UV detector
Loading...
Date
2015
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
UNIVERSITY OF MANAGEMENT AND TECHNOLOGY
Abstract
Milk Thistle (Silybum marianum) is a wild, herbaceous plant. Generally the extract of Silybum marianum is expressed as total Silymarin. Silymarin is composed of flavonolignans, silybin, silydianin and silychristin. Out of these compounds, silybin is considered the most vital as it plays an important role for the treatment of liver disorder. Silymarin is very important natural drug which is widely used for the treatment of variety of diseases, especially for hepatic disorders. A novel, reliable and a sensitive method to determine the amount of Silymarin was developed by using reversed phased HPLC method with isocratic solvent delivery. Silymarin was separated using Hypersil ODS C18 column maintaining temperature at 40°C in the column oven and detector was set at wavelength 288 nm with mobile phase in a ratio Methanol:Water:Phosphoric acid (46:54:0.1 v/v/v). The silymarin was tested with respect to silybin which is the most vital and pharmacological active substance. For this purpose the retention time of the silybin among all flavonolignans were determined by injecting silybin standard. Then the silymarin standard and silymarin raw material sample were injected and successfully determined the assay of silymarin. The developed method was then validated as per ICH guidelines. Linearity, accuracy, precision and robustness are the key parameters used to validate the method. This method could easily be used for the determination of silymarin for routine analysis of raw material to maintain its quality and to check the efficacy of the incoming consignments of raw material.
Description
SUPERVISOR: DR. Sammia Shahid
Keywords
MS Thesis, Validation of silymarin, Silybum marianum, RP-HPLC WITH UV detector