Preformulation, stress stability studies and HPLC-UV method development and validation for 95 % ethanol extract of Moringa oleifera Lam. Leaves

Abstract

Introduction: There is a continuous expansion in number of botanical medicinal products and increase in consumers who often use it. One of such natural source products with versatile traditional uses as treatment for variety of diseases is Moringa oleifera Lam. Objectives: After the pharmacological activity of a new drug candidate is approved, the subsequent development of this product requires substantial information about its physical and chemical properties before designing its dosage form. Methods: Organoleptic properties, physicochemical characteristics, solubility profile, swelling index, partition coefficient, analyses of thermal behaviour, stress stability, heavy metals and microbial limit tests were performed in preformulation studies of 95 % ethanol extract of M. oleifera leaves. Results: The results of preformulation studies illustrated several characteristic properties that should be consider during formulation of Moringa extract. In addition to that, a HPLC-UV method for simultaneous detection and quantification of three reference markers was developed and validated. Conclusion: The 95 % ethanol extract of Moringa leaf is relevant to the development of phytomedicines, dietary supplements or cosmetics. To the best of our knowledge, the present study is the first preformulation study which aimed to determine the physicochemical properties of 95 % ethanol extract of Moringa oleifera leaf.