NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF UV -VISIBLE SPECTROSCOPY ANDUSING FTIR STUDY OF CHEMICAL STRUCTURE OF SULPIRIDE

Nandankumar K.*, Kushala P., Harshitha A. S., Shankar Prasad D. B., Sanjay S.

ABSTRACT

Development and implementation of a simple, precise, and Accurate Zero order spectroscopic method for the estimation of Sulpiride in bulk and Tablet dosage form. The drug indicates the maximum absorption (λmax) at 212 nm in 0.2N HCl solutions and AUC in the absorption spectrum is measured in the wavelength range from 207 to 218 nm at a concentration range of 1-5μg/ml according to Beer’s law. Linearity analysis showed an R2 value of 0.998. The LOD & LOQ were found to be 0.0110 and 0.33 μg/ml. The %RSD was found less than 2%. The method has been validated according to Linearity, Precision, Accuracy, Robustness, Ruggedness, LOD and LOQ according to ICH guidelines. This method obeys the Beer’s law and met all the required specifications within the limit. FTIR analysis of Sulpiride active pharmaceutical ingredient gives different peaks of wavenumbers. FTIR data interpretation also gives information about purity and quality of sample and it also meets the required specifications.

Keywords: Sulpiride, UV Spectroscopy, FTIR, ICH Guidelines.