ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND DETERMINATION OF ARTESUNATE IN PHARMACEUTICAL TABLET FORMULATIONS
Journal Title: World Journal of Pharmaceutical and life sciences - Year 2018, Vol 4, Issue 2
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 λmax 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.
Authors and Affiliations
Fateh AL Rahman Magbool
Keywords
Related Articles
- EP ID EP650645
- DOI -
- Views 168
- Downloads 0
GENDER DIFFERENCES IN PARASYMPATHETIC REACTIVITY AMONG HEALTHY, NEPALI MEDICAL STUDENTS
Autonomic function test is a non invasive measure of autonomic reactivity to different stressors. This study was undertaken to determine the effect of gender on parasympathetic reactivity in healthy, Nepali medical stude...
LAGHUGANGADHARA CHURNA, A POLYHERBAL FORMULATION FOR DIARRHEA – A REVIEW
Herbal medicines are significant and reliable sources for treating various infectious and non infectious diseases. It is well known that infectious diseases account for high proportion of health problem, especially in de...
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF FLUOROMETHOLONE USING C8 COLUMN IN PARENTERAL DOSAGE FORM BY UPLC TECHNOLOGY
A specific, precise, accurate UPLC method is validated for estimation of Fluorometholone in parenteral dosage form. The method employed, with C8 column (250 ×4.6 mm id)—ACE Generix in gradient mode, with mobile phase of...
FORMULATION AND DEVELOPMENT OF ENALAPRIL MALEATE FAST DISSOLVING TABLETS BY DIRECT COMPRESSION METHOD AND ITS PHARMACEUTICAL EVALUATION
In the project work Enalapril maleate, an anti hypertensive drugs has been formulated into fast dissolving tablets by direct compression method using the different super disintegrates such as croscarmellose and sodium st...
SHORT TERM EFFECTS OF FENOTEROL ON CARDIAC MUSCLE OF MICE
Beta- adrenergic agonists (Fenoterol, Clenbuterol) are sympathomimetic substances which are capable of activating both β1 and β2 adrenoceptors in vivo. These drugs produce effects equivalent to those produced as a result...