Abstract
STABILITY INDICATING HPTLC METHOD DEVELOPMENT FOR FEXOFENADINE HYDROCHLORIDE

Birva A. Athavia*, Dr. Zarna R. Dedania, Dr. Ronak R. Dedania, Dr. S. M. Vijayendra Swamy and Chandrika T. Dobariya

ABSTRACT

A highly selective, sensitive and robust stability indicative HPTLC method was developed and validated for Determination of Fexofenadine Hydrochloride in bulk for degradation studies, stability studies as well as in formulation. The chromatography was performed on pre-coated silica gel 60F254 aluminum plate using the mobile phase Hexane: Methanol: Tri-Ethyl amine (6:4:0.1 v/v/v) with UV detection at 234 nm with Rf 0.68 ± 0.02. The method was demonstrated to be precise, accurate and specific with no interference from the tablet excipients and was able to separate the drug from the degradation products produced under Acidic, Alkaline, Oxidative, Photolytic and Thermal Degradation condition. The method was validated for Linearity, Specificity, Precision, Accuracy and Robustness as per ICH guidelines. The Linearity of peak area responses was demonstrated within the concentration range of 1000-6000ng/spot with R2= 0.9904. The Limits of Detection and the Limits of Quantitation were 623.59 and 1889.66 ng/spot respectively. The Accuracy determined at 80, 100 and 120% levels was found to be within 99.81 % ± 0.76 and 101.01 % ± 0.99. Fexofenadine Hydrochloride was found to be degraded 11.1% in Acidic Condition, 7.88% Alkaline Condition, 14.55% Oxidative Stress Condition, 2.51% Photolytic Condition and 5.78% Thermal Condition. It was found that oxidative condition is more susceptible to degradation of drug, whereas photolytic condition is least susceptible to degradation of drug. The results indicated that the proposed method can be used as a Stability Indicating Method for estimation of Fexofenadine Hydrochloride.

Keywords: Fexofenadine Hydrochloride, HPTLC, Method Validation, Stability Indicating Method.


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