Abstract

A VALIDATED STABILITY INDICATING METHOD FOR THE ESTIMATION OF DICLOFENAC ACID IN BULK AND DOSAGE FORMS USING LC-PDA

Calamur Nagarajan Nalini*, Kondaviti Sahini and Alapati Teja

ABSTRACT

A stability indicating RP-HPLC analytical method for the estimation of Diclofenac acid in bulk and pharmaceutical dosage form was developed and validated using Waters X-Bridge C18 (50 × 4.6mm, 5μ) column using pH 5.3 acetate buffer and organic mixture in the ratio 55:45 in isocratic flow at 1 ml/min. The detection was carried out using PDA detector at 280nm. The retention time was found to be 2.634 mins. The Linearity studies were carried out from 25 – 75μg/ml of diclofenac acid. The correlation coefficient (r2) was found to be 0.998. The percentage recovery (Accuracy) at each level of 25 –300% was within the 98 – 102%. Diclofenac acid was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Peak purity analysis using the Photo Diode Array detector and demonstrated. Diclofenac acid peak homogeneity. The study validates the method is specific and stability indicating. The method was developed and validated according to the ICH guidelines.

Keywords: Diclofenac acid, RP-HPLC, Validation, Stability indicating, ICH guidelines.