Abstract

ANALYTICAL METHOD DEVELOPPMENT AND VALIDATION OF ROSIGLITAZONE TABLETS DOSAGE FORM RP-HPLC

Paresh Ravindra Patil*, Shabnam Khan, Ramakant Sharma Jeevan Patel and
Dr. Rakesh Patel

ABSTRACT

A HPLC method for Rosiglitazone tablets was developed and validated in tablet dosage form as per ICH guide lines. The results of this validation are as summarized in the report. The results are found to be complying with the acceptance criteria for each of the parameter. Waters Alliance HPLC (Empower software with PDA detector) with Zorbax Eclipse XDB, C8,150 x 4.6mm, 5µ column, Injection volume of 10 µl is injected and eluted with the Mobile phase (Buffer and ACN, in the ratio of 65:35) which was pumped at a flow rate of 1.5 ml at 250 nm. The peak of Rosiglitazone was found well separated at min. The developed method was validated for various parameters as per ICH
guidelines like system suitability, accuracy, precision, linearity, specificity, ruggedness, robustness and solution stability. Hence it is concluded that the assay method is found to be valid in terms of reliability, precision, accuracy and specificity and hence it is suitable for routine analysis as well as for stability analysis.

Keywords: Analytical Method, Rosiglitazone, Rp- HPLC.