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Abstract

DEVELOPMENT OF FORCED DEGRADATION METHOD AND VALIDATION FOR THE ESTIMATION OF DEXRABEPRAZOLE IN MARKETED FORMULATION

Ashna Prasad*, Dr. Narendra Pratap Sengar**, Mr. Manish Sharma***, Dr. Jitendra Banweer****

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Abstract

In the present research work, a successful attempt was made for “Development of forced degradation method and validation for the estimation of Dexrabeprazole in marketed formulation” which was developed by experimentation based on thorough literature survey and ascertained by statistical parameters of sampling. The simplicity, rapidity, accurate and reproducibility of the proposed methods completely fulfill the objective of the research work of estimation of the drug in blood plasma. Liquid chromatographic system from waters comprising of manual injector, waters 515 pump for constant flow and constant pressure delivery and U.V. Vis. Detector connected to data ace software for controlling the instrumentation as well as processing the data generated were used. Drug sample was extracted by precipitating method using 5ml of methanol for each ml of plasma sample. The proposed methods were found to be linear with correlation coefficient close to one. Precision was determined by repeatability, Intermediate precision and reproducibility of the drugs. The robustness of developed method was checked by changing in the deliberate variation in solvent. The result obtained shows the developed methods to be Cost effective, Rapid (Short retention time), Simple, Accurate (the value of SD and %RSD less than 2), Precise and can be successfully employed in the routine analysis of these drugs in bulk drug as well as in tablet dosage form. The Simplicity, Rapidly and Reproducibility of the proposed method completely fulfill the objective of this research work.

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