Development and validation of Analytical methods for Antidiabetic Polyherbal Formulation

Abstract

Diabetes mellitus is the most common endocrine disorder, affecting 16 million individuals in the United States and 200 million worldwide. Despite the use of advanced synthetic drugs for the treatment, use of herbal remedies is gaining higher importance because of synthetic drugs have drawbacks and limitations. Antidiabetic herbal formulations (AHF) are considered to be more effective for the management of diabetes. In recent days, different formulations are available which are used for management of Diabetes. So, present investigation was undertaken with a view to develop Different Analytical methods for simultaneous estimation of Gallic acid, Ellagic acid and Curcumin, markers present in different antidiabetic Polyherbal formulations so as we can measure them in very precise manner. Most sensitive RP-HPLC method by applying QbD concept was developed and further LC-MS/MS study was performed to differentiate Curcumin from other Curcuminoids. HPTLC Method was developed by using less amount of solvents and with good resolution of peaks which is very helpful for early phase of formulation development. Chemometric Methods (CLS and ILS) were developed which are capable to determine constituents in presence of matrix very accurately. UV spectrophotometric Methods (Absorbance correction method and First order derivative) were developed as they are very much convenient and less time consuming and also possible for small scale industries. All developed methods were validated according to ICH guideline and statistical comparison was done by ONE WAY ANOVA method. Developed Analytical methods can be widely used in recent era as this is a prime requirement for dossier submission and commercial acceptability newline newline