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Indian Journal of Pharmacy and Pharmacology


ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES OF TRAMADOL HYDROCHLORIDE


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Author Details: Ravindra K Kamble, Chetan Singh Chauhan, Priyadarshani R Kamble

Volume : 2

Issue : 2

Online ISSN : 2393-9087

Print ISSN : 2393-9079

Article First Page : 100

Article End Page : 104


Abstract

A simple, sensitive and reproducible UV Spectroscopic method was developed for the quantitative determination of Tramadol Hydrochloride. The λmax 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 coefficientR²in 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.

Doi No:-10.18231