World Journal of
Pharmaceutical and Life Sciences

ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND DETERMINATION OF ARTESUNATE IN PHARMACEUTICAL TABLET FORMULATIONS

Fateh AL Rahman Magbool* and Mahmoud ElAoud Ibrahim

ABSTRACT

Resistance to conventional antimalarials triggered off new policies to circumvent the devastating consequences of malaria especially in the trans-Saharan Africa. The use of artemisinin-based combinations as first line drug in treatment of uncomplicated malaria was then advocated and adopted by the World Health Organization (WHO). Artesunate (ARTS) is the most widely used of the artemisinin derivatives. It is an antimalarial agent. It is a water-soluble hemisuccinate derivative of artemisinin. In Sudan, artesunate tablet is the commonest artemisinin product in the market and is available in various strengths from both local and foreign manufacturers. The quality of these antimalarials if not properly safeguarded could lead to therapeutic failure in patients and the development of drug resistance. A simple and sensitive spectrophotometric method is developed for the determination of Artesunate (ARTS) in tablet formulations. Due to difficulty to detect and identify Artesunate by standard spectrophotometric methods, since it absorbs light only at low wavelengths, has a relatively low molar extinction coefficient, and has no distinct UV-Visible spectrum or fluorescent properties. In order to assay ART by developed UV method, it is necessary to involve it in a reaction process that would break the endo-peroxide ring and introduce a least one double bond in the molecule and this can be achieved by reacting it with sodium hydroxide for generation of chromophore needed for UV Spectroscopy. Ultraviolet absorption spectroscopy was used to establish the wavelength of maximum absorbance for pure powder of artesunate and then the Beer’s plot generated. This was used to evaluate the quality of four brands (X1-X4) of artesunate in Sudan drug market, The accuracy and validity of the method was validated, and the results evaluated by performing recovery studies via standard addition method. Artesunate was determined spectrophotometrically at ?max 289. Beer’s law was obeyed in the range of 0.02-0.1mg/ml, with regression coefficient of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) determined as per the current ICH guidelines were found to be 0.01mg/ml and 0.02mg/ml respectively. The accuracy and precision was expressed. The validated proposed method was used to assay ARTS in commercial tablets brands and the results showed good congruence with the reference methods (titration). The accuracy and validity of the proposed method was evaluated by performing recovery studies via standard addition method, the results showed excellent recoveries with no appreciable interference from excipients.

[Full Text Article]   [Download Certificate]