METHOD DEVELOPMENT AND VALIDATION OF A FAST AND SENSITIVE HPLC AND UV-VIS SPECTROPHOTOMETRIC TECHNIQUE FOR THE ESTIMATION OF RIVASTIGMINE IN BULK AND FORMULATION

Abstract

This study developed and validated rapid, sensitive analytical methods for Rivastigmine Tartrate, a reversible cholinesterase inhibitor used in Alzheimer’s treatment. Utilizing principles of analytical chemistry to ensure pharmaceutical quality, three techniques were evaluated: HPLC, UV, and Visible Spectrophotometry. The HPLC method employed a Zorbax XDB C18 column with a 70:30 buffer-to-methanol isocratic mobile phase, achieving a retention time of ~5.7 minutes. Spectrophotometric analysis included a UV method validated at 263.29 nm and a visible method using Bromocresol green at pH 4. All methods were validated per ICH guidelines for accuracy, precision, linearity, and robustness. Validated per ICH guidelines, all methods met strict criteria for accuracy, precision, linearity, and robustness. The results confirm these procedures are rapid, sensitive, and reliable for the quantitative analysis of Rivastigmine in both bulk drugs and dosage forms.