DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF RANITIDINE AND ONDANSETRON IN BULK AND PHARMACUTICAL FORMULATION
Vaibhav R. Mandale*, Dr. Subhash S. Palekar, Dr. Prakash T. Sangale, Dr. Tauqueer Kadu, Dr. Atul S. Sayare, Archana M. Karnik.
Abstract
An accurate, specific and precise UV spectrophotometric method was
developed for the simultaneous determination of Ranitidine (RAN) and
Ondansetron (OND) in injection dosage form. The optimum conditions
for the analysis of the drug were established. The maximum
wavelength (λmax) was found to be 230 nm for RAN and 216 nm for
OND. The linearity of the proposed method was found in the range of
50-200 μg/ml and 8-32 μg/ml for RAN and OND respectively.
Calibration curves showed a linear relationship between the
absorbance and concentration. The line equation for RAN Y =
0.0222X - 0.0226 with r2 of 0.9999 and for OND Y = 0.0292X -
0.0149 with r2 of 0.9998 was obtained. Validation was performed as
per ICH guidelines for linearity, accuracy, precision, LOD and LOQ.
The LOD was found to be 0.0454 and 0.656 μg/ml for RAN and OND
and the LOQ was found to be 0.151 and 2.18 μg/ml for RAN and OND respectively. The
proposed method was simple, sensitive, precise, accurate, quick and useful for routine
analysis of RAN and OND in injection formulations.
Keywords: Simultaneous equation method, Validation, Ranitidine, Ondansetron, UV spectrophotometry.
[Full Text Article]