Abstract
DEVELOPMENT AND VALIDATION FOR ESTIMATION OF RIVASTIGMINE BY USING RP-HPLC AND UV-SPECTROPHOTOMETRY

Roopa Chirala* and Saisindhu Gande

ABSTRACT

A simple, precise and accurate RP-HPLC and UV-Spectrophotometric method was developed and validated for determination of Rivastigmine in capsule dosage form. Chromatography was carried out by using binary isocratic elution at a flow rate of 1ml/min was employed on a symmetry Phenomenex C18 (250x4.6mm, 5μm in particle size) column at ambient temperature. The mobile phase consisted of Methanol: (0.01M) Ammonium formate (pH 4.0) at the ratio of 50:50 and 20μl sample was injected. The retention time for Rivastigmine was 3.80 min. Calibration curve was plotted with a range of 1-64μg/ml with correlation coefficient of 0.999 for RP-HPLC method. UV-Spectrophotometry method was developed and validated by using the same mobile phase. Calibration curve was plotted with a range of 5-30μg/ml with correlation coefficient of 0.998. The assay was validated in terms of linearity, precision, accuracy, specificity, limit of detection, limit of quantification and robustness. The percentage RSD values for all parameters were found to be less than 2% for RP-HPLC and UVSpectrophotometric method. The proposed method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Rivastigmine in capsule dosage form and standard drug.

Keywords: Rivastigmine, RP-HPLC, UV-Spectrophotometry, Methanol, Ammonium formate, ICH guidelines.


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