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Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR TRAMADOL HYDROCHLORIDE

Smita Nayak*, Varshakumari Singh and Vaidhun Bhaskar

ABSTRACT

The objective of the study is to develop simple, precise and accurate UV spectrophotometric method for analysis of Tramadol hydrochloride (TH) from bulk drug as well as formulation. The drug was dissolved in a suitable solvent and its absorption pattern over the wavelength of 200-400 nm was studied. The drug exhibited absorption maxima at 272 nm. The calibration curve was plotted and found to obey Beer-Lamberts law in the concentration range of 25-150 μg/ml with regression coefficient of 0.996. The method was successfully validated as per ICH guidelines. The developed method was found to be suitable for routine quality control analysis of Tramadol hydrochloride From bulk as well as formulation without interference of excipients.

Keywords: Tramadol hydrochloride ? linearity ? precision ? accuracy ? robustness? ruggedness.


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