Indian Journal of Pharmacy and Pharmacology
  • Year: 2015
  • Volume: 2
  • Issue: 2

Analytical method development and validation studies of tramadol hydrochloride

  • Author:
  • Ravindra K Kamble1,, Chetan Singh Chauhan2, Priyadarshani R Kamble3
  • Total Page Count: 5
  • Page Number: 100 to 104

1Faculty of Pharmacy, Pacific Academy of Higher Education and Research University, Udaipur, Rajasthan, India

2B N Institute of Pharmaceutical Sciences, Udaipur, Rajasthan, India

3B N College of Pharmacy, Udaipur, Rajasthan, India

*Corresponding Author: E-mail: ravi.kamb@gmail.com

Online published on 28 July, 2016.

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 coefficient R2 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.

Keywords

Tramadol hydrochloride, UV spectroscopic, Validation, ICH Q2 (R1) guidelines