Abstract

DEVELOPMENT AND VALIDATION OF ULTRA VIOLET SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF ACID DISSOCIATION CONSTANT OF TRAMADOL HYDROCHLORIDE

Yogesh Matta, Anjoo Kamboj*, Vikas Kohar

Abstract

In the present study a simple, accurate, precise and economical UV spectrophotometric method for determination of acid dissociation constant (pKa) of tramadol hydrochloride has been developed. The wavelengths selected for ionized and unionized forms of tramadol hydrochloride were 209nm and 269nm respectively using buffer solutions as solvent. The relative concentrations of the ionized and unionized forms of the drug were determined by simultaneous equation method and determined the pKa value using Handerson – Hasselbalch equation. Using absorbance values, absorptivity values and simultaneous equation the concentration of ionized and unionized form of drug was determined and using Handerson-hasselbalch equation the pKa was found to be 9.3. The method utilizes easily available and cheap solvent for analysis hence the method was also economic. The method was validated statistically for accuracy, precision, reproducibility, linearity, LOD, LOQ and robustness & ruggedness. Hence the method could be conveniently adopted for routine analysis in quality control laboratories.

Keywords: Tramadol hydrochloride, UV spectrophotometer, simultaneous equation method, method validation..