Abstract

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF RANITIDINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Swati S. Rawat*

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Abstract

A rapid, simple, selective and precise UV- Visible Spectrophotometric method has been developed for the determination of Ranitidine Hydrochloride in bulk forms and tablet dosage formulations. The spectrophotometric detection was as per carried out at an absorption maximum of 322 nm using 0.1N HCl as solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for was linear over the selected concentration range 2-14 ug/ml with a correlation coefficient of 0.9984. The accuracy was carried out as per recovery study and found between 98% to 102%. The results demonstrated that the excipients in the tablets did not interfere with the method and can be conveniently employed for routine quality control analysis of Ranitidine Hydrochloride in bulk and in dosage formulations.

Keywords: UV Spectroscopy; Method Development; Validation; Ranitidine Hydrochloride, 0.1N HCl and ICH Guideline.