EFFECT OF CLASSICAL AND LYOPHILIZED DRYING METHODS ON STABILITY OF JUSTICIA ADHATODA L. POWDER

Abstract

Background: Recent advances in various drying techniques play a significant role in the stability and efficacy of the drug. Powder formulation is the most widely used dosage form. Aim: To evaluate the stability of classically and lyophilized prepared leaves powder of Justicia Adhatoda L. through accelerated stability study as per ICH guideline Q1A .Materials and Methods: The raw material was collected from the botanical garden of Government Ayurveda Pharmacy, Rajpipla and was certified by Pharmacognosy Department, Food and Drug Laboratory, Vadodara. The drying process of Vasa leaves was done by two different methods, one naturally in shade and the other by lyophilization. Both the samples were subjected to accelerated stability study following standard ICH guideline Q1A. For that organoleptic, Physico‑chemical parameters, quantitative HPTLC analysis, heavy metal and microbial contamination were evaluated at specific intervals. Results: The study showed that no significant changes were observed in the organoleptic and physicochemical parameters up to 6 months of controlled storage under accelerated conditions. Microbial load and heavy metals were found within permissible limits in both the samples. The results of various physicochemical parameters of the initial month were considered to evaluate the intercept and slope. Conclusion: It can be inferred that the shelf life of shade dried and lyophilized powder of Vasika leaves is 2.22 and 4.43 years respectively.