DEVELOPMENT AND VALIDATION OF ARTEMETHER & LUMEFANTRINE IN PHARMACEUTICAL DOSAGE FORMS

The developed method was validated for parameters such as System suitability, Precision, Accuracy, Linearity and Robustness for the assay of Artemether + Lumefantrine. Hence the method is suitable, linear, precise, accurate and robust for the assay of Artemether and Lumefantrine. Precision and Accuracy are the major control parameters of the whole validation procedure were within the acceptable limits. The experimental data makes a relevant contribution to the understanding of validation parameters.The present work shows a validated, highly sensitive and selective method for determination of Artemether (20mg) + Lumefantrine (120mg) in tablet dosage forms. Key Word: Precision , Validation, Dosage Forms INTRODUCTION Chromatography is a technique by which the components in a sample, carried by the liquid or gaseous phase, are resolved by sorption-desorption steps on the stati onary phase. [1-3] HPLC is a type of liquid chromatography that employs a liquid mobile phase and a very finely divided stationary phase. In order to obtain satisfactory flow rate liquid must be pressurized to a few thousands of pounds per square inch. The HPLC is the method of choice in the field of analytical chemistry, since this method is specific, robust, linear, precise and accurate and the limit of detection is low and also it offers the following advantages.Speed (many analysis can be accomplished in 20 min or less), Greater sensitivity (various detectors can be employed) Improved resolution (wide variety of stationary phases), Reusable columns (expensive columns but can be used for many analysis), Ideal for the substances of low viscosity, Easy sample recovery, handling and maintenance. Instrumentation leads itself to World Journal of Pharmaceutical Research SJIF Impact Factor 7.523 Volume 6, Issue 10, 749-767. Research Article ISSN 2277– 7105 *Corresponding Author Dr. A. Rajesh Hindu College of Pharmacy, Guntur-522 002. Article Received on 09 July 2017, Revised on 29 July 2017, Accepted on 19 August 2017 DOI: 10.20959/wjpr201710-9352