Abstract

DEVELOPMENT AND VALIDATION OF RAPID AND SIMPLE HIGH PERFORMANCE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TRAMADOL HYDROCHLORIDE FROM BULK AND FORMULATION

Smita Nayak, Varsha Kumari Singh*, Vaidhun Bhaskar

Abstract

The objective of the study is to develop simple, precise, selective and stability indicating high-performance liquid chromatography (HPLC) method for determination of Tramadol hydrochloride (TH) in bulk and from formulation. The chromatographic conditions comprised a reverse-phase C18 column, mobile phase consisting of a mixture of Orthophosphoric acid, in 2000 ml of milli-Q water (pH 6.5 adjusted with Tri ethyl amine) and Acetonitrile in the ratio of 60:40. The flow rate was adjusted to 0.8 ml/min and the detection was carried out at 273 nm. The retention time of TH was 3.1 min. The linear regression analysis data for calibration plots showed good linear relationship with coefficient of correlation value, r = 0.996 for TH in the concentration ranges of 30-50 μg/ml. The method was validated for precision, accuracy and robustness. The developed method was found to be suitable for routine quality control analysis of TH from bulk as well as formulation without interference of excipients.

Keywords: Tramadol hydrochloride ? stability indicating method ? precision ? accuracy ? robustness.