Abstract

Sunil Kumar Yelamanchi V ¹, Useni Reddy Mallu² , I. V Kasi Viswanath^1*, D. Balasubramanyam³ and G. Narshima Murthy⁴

DOI : http://dx.doi.org/10.13005/ojc/320502

The main objective of this study was to develop a simple, efficient, specific, precise and accurate newly improved modified Reverse Phase High Performance Liquid Chromatographic Purity (or) Related substance method for bromofenac sodium sesquihydrate active pharmaceuticals ingredient dosage form. Validation of analytical method is the confirmation by examination and the provision of   objective evidence that the particular requirements for a specific intended use are fulfilled as per ICH, USP, BP or any other suitable regulatory guidelines. The Reverse Phase High Performance Liquid Chromatographic Gradient method was developed by utilizing Waters Symmetry C8, 150x4.6mm, 3.5µm on Waters 2487 series Liquid Chromatograph. The retention time of bromofenac sodium sesquihydrate was found to be 5.973minutes. Considering all the results of validation parameters simplicity of the method and the cost effectiveness of the overall procedure, it is possible to conclude that the developed method can be suitable for the regular quality control determination of bromofenac sodium sesquihydrate in bulk as well as pharmaceutical dosage form.The developed Reverse Phase High Performance Liquid Chromatographic Purity (or) Related substance  method for bromofenac sodium sesquihydrate active pharmaceuticals ingredient method was validated with respect to System Suitability , linearity, , precision ,Range, Ruggedness, Test Solution and Mobile phase stability ,Robustness..

Bromofenac sodium sesquihydrate; Reverse Phase High Performance Liquid Chromatographic Purity (RPHPLC); Determination; Validation; Pharmaceutical dosage form

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