Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ANALYSIS OF NORTRYPTALINE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM

Jain H. K.* and Pethkar S. V.

ABSTRACT

The objective of present work was to develop a simple, accurate, sensitive, precise and economical spectroscopic method for the determination of Nortryptaline hydrochloride in bulk and tablet dosage form. The corresponding wavelength to maximum absorbance of drug was found at 238.4 nm. The linearity was found in the concentration range of 5-25 μg/ml and exhibited good correlation coefficient (R2=0.9998) with mean % recovery (98.10-99.41%). The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.125μg/ml and 0.381μg/ml, respectively. The method was validated for several parameters like accuracy, precision, linearity as per ICH guidelines. The values of relative standard deviation and percentage recovery were found to be satisfactory; that indicate the proposed method is precise, accurate and economical hence can be used for the routine analysis.

Keywords: Nortryptaline Hydrochloride, UV spectrophotometry, Validation, Assay, ICH Guideline.