ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES OF TRAMADOL HYDROCHLORIDE


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Article type :

Original Article

Author :

Ravindra K Kamble, Chetan Singh Chauhan, Priyadarshani R Kamble

Volume :

2

Issue :

2

Abstract :

A simple, sensitive and reproducible UV Spectroscopic method was developed for the quantitative determination of Tramadol Hydrochloride. The ?max of the tramadol hydrochloride was observed and recorded to be 271.00nm in distilled water as well as in the phosphate buffer pH 6.8 and it complies with the requirement of the standard texts. Correlation coefficientR?2;in distilled water was 0.998 and of buffer solution was found as 0.997.The method was validated as per ICH Q2 (R1) guidelines and confirmed a good performance complies with respect to linearity, accuracy, and precision, range limit of detection and limit of quantification. So the proposed method can be used in routine quality control laboratories. Key Words: Tramadol hydrochloride, UV spectroscopic, Validation, ICH Q2 (R1) guidelines.