Abstract
QBD APPROACH TO UV-VISIBLE SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RANOLAZINE IN BULK AND PHARMACEUTICAL FORMULATION

Amiksh Pukale*, Snehal Giri and Santosh Waghmare

ABSTRACT

A rapid and sensitive UV-Visible spectroscopic method was developed for the estimation of Ranalozine in pure and its Pharmaceutical formulations. The method was validated as per International Conference on Harmonization [ICH] guidelines. The Ranalozine was monitored at 272.5nm with UV detection and there is interference of diluent at 272.5nm for Ranalozine. The method was linear (r2 =0.999) at concentration ranging from40 to 90μg/ml, precise (intra-day relative standard deviation [RSD] and inter-day RSD values < 2.0%), accurate (mean recovery = 100.2%), specific and robust. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of Ranalozine in bulk, it solid dosage forms.

Keywords: Ranalozine, UV-Visible spectroscopy, Validation, Dosage form.


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