Development Of Nano-Formulation Using Pvp/P407 Based On Solid Dispersion From Standardised Ethanolic Extract Of Orthosiphon Stamineus Leaf For Solubility And Oral Bioavailability Improvements
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Date
2017-08
Authors
Saidan, Noor Hafizoh
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Publisher
Universiti Sains Malaysia
Abstract
This study involved the quality assessment of Orthosiphon stamineus raw materials, standardisation of different extracts, development of nano-formulation using macerated ethanolic extract and evaluated for selected biological activities (antioxidant and cytotoxicity). The dried leaves of O. stamineus fulfilled the physicochemical properties, heavy metals and microbial limits to be used for further study. Five different extracts namely methanolic, methanolic (50%), ethanolic, ethanolic (50%) and water were obtained using three different techniques (Soxhlet, reflux and maceration). The spectroscopic (FTIR and UV) and chromatographic (HPLC) analysis were carried out for standardisation of the crude extracts. The results revealed the flavonoids and phenolic acids were the major chemical constituents in O. stamineus extracts. An improved RP-HPLC/DAD method was validated for the quantitative analysis of rosmarinic acid (RA), 3-hydroxy-5, 6, 7, 4-methoxyflavone (TMF), sinensetin (SIN) and eupatorin (EUP) in the crude extracts. This method was applied in the pharmacokinetic and stability studies in the extract and formulated extract. RP-HPLC/DAD method validation including specificity, linearity (R2 ≥ 0.999), precision (intra- and inter-day) and recoveries (90.2-104%). The LOD and LOQ of this selected compounds were in the range of 0.17 ± 0.01 to 0.24 ± 0.03 μg/mL and 0.53 ± 0.03 to 0.73 ± 0.09 μg/mL, respectively. The FTIR fingerprint and HPLC data set were analysed using chemometric tools (PCA and HCA) for its metabolite contents (primary and secondary) and selected activities.
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Keywords
Development of nano-formulation using macerated ethanolic extract , for selected biological activities antioxidant and cytotoxicity