No abstract

Artemether-lumefantrine is the most widely used artemisinin-based combination therapy for malaria. The present work aims to develop and validate a simple, accurate, precise and rapid ratio first order derivative spectrophotometric method for the simultaneous estimation of artemether and lumefantrine in a fixed dose combination tablet. The first step in development of the method was to derivatize artemether. As artemether does not show absorption in the UV region, it was derivatized using hydrochloric acid as the derivatizing agent. The derivatizing conditions were further optimized by full factorial multivariate approach, where the independent variables were volume of concentrated hydrochloric acid and time taken for artemether derivatization at room temperature. Furthermore, based on the statistical analysis, derivatizing conditions were optimized i.e. 1.3 ml of conc. HCl at room temperature for 30 min. At this condition, the artemether was found to absorb in the UV region satisfactorily, and the absorbance of lumefantrine was found to remain unaffected. The developed method showed good calibration data in the range of 5-30 g/ml for artemether and 2-12 g/ml for lumefantrine. The mean % recovery values were found to be 99.96-100.49% and 99.48-100.31% for artemether and lumefantrine, respectively. Additionally, the developed method was effectively applied in the estimation of artemether and lumefantrine in a commercial tablet (ARH-L DS tablets), suggesting that it can be practically applied for quality control of routinely examined drugs in combined dosage forms with the reduced expenditure of time.

Introduction: To develop and optimize viscous eye drop for dorzolamide hydrochloride and timolol maleate used in Glaucoma-the leading cause of irreversible blindness worldwide. Methods and Materials: 32 full factorial design was applied in formulation optimization to study the relationships between critical process parameters (concentration of HPMC K15 and Carbopol 934) and critical quality attributes, i.e. viscosity, mucoadhesion index and cumulative drug release for both the drugs. Further, the optimized formulation was identified through derringer's desirability approach of multicriteria decision making technique and was fully characterized in terms of molecular interactions (DSC and FTIR) as well as in vitro and in vivo biological properties, including biological sensitivity/irritation studies performed on rabbits. Moreover, in vivo ocular pharmacokinetic study was performed using developed bioanalytical RP-HPLC method having mobile phase phosphate buffer (pH 6.8): methanol: Acetonitrile, 45:45:10 v/v/v in rabbit tear fluid employing protein precipitating sample preparation technique. Results: Results revealed that optimized batch does not have any ocular irritancy on rabbit eye and shows increase in mean residence time compared to marketed formulation. Conclusion: Hence, the design planning methodology clearly showed its usefulness for optimizing the formulation and the formulated Viscous eye drop proved to be a promising formulation strategy for ophthalmic delivery of dorzolamide and timolol maleate making it a potential alternative for the marketed formulation.

No abstract

No abstract