Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF MISOPROSTOL BY UVSPECTROPHOTOMETRY

*Arunima Aravind V. P., Dr. Ajith Babu T. K., Fathimath Shahama C., Megha M.

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Abstract

A UV spectrophotometric technique for quantifying misoprostol in bulk and pharmaceutical formulations has been developed and validated. Distilled water is utilized as solvent because misoprostol dissolves in it. Misoprostol was dissolved in distilled water and scanned in the UV range (200–400nm). The λmax (absorption maxima) of the drug was found to be 208nm. In the concentration range of 1 to 5 g/ml, Beer's law holds true. Accuracy, precision, linearity, robustness, LOD, and LOQ were all validated in the devised approach. With a correlation coefficient of 0.9980, linearity was achieved in the 1-5g/ml range. 2.0924g/ml and 6.3406g/ml, respectively, were found to be the LOD and LOQ. As a result of the method's high reproducibility and repeatability, it may be used for routine analysis of misoprostol in bulk.

Keywords: Misoprostol, UV spectrophotometric method, Validation, ICH.