A. Chandra Prabha1, M. Sankar2 and A. Chenthilnathan1*
1Department of Pharmaceutical Chemistry, Manonmaniam Sundaranar University, Tirunelveli–627012, Tamil Nadu, India.
2Caplin Point Laboratories Ltd., Gummidipoondi, Chennai–601201, Tamil Nadu, India
A B S T R A C T
A stability-indicating RP-HPLC was developed and validated for the determination of Piroxicam in bulk and its injection dosage form. The separation was carried out on Waters Nova pack C18 coloum (150 × 3.9mm; 4µm) column at ambient temperature using buffer and methanol (50:50) as eluent. The flow rate was 1.0 ml/min and Piroxicam was quantified by absorbance at 240 nm. The retention time of Piroxicam was 4.50 min. The percentage recovery was within the range between 100.20 % and 100.70% for Piroxicam. The linear ranges were found in the range of 50µg/ml – 150µg/ml (r2 = 0.999) of Piroxicam.. The percentage relative standard deviation for accuracy and precision was found to be less than 2%. Piroxicam was subjected to stress conditions including acidic, alkaline and oxidative degradation. It was found that, Piroxicam is more sensitive towards oxidative degradation. The proposed method was validated as per ICH guidelines.
Keywords: Reversed-phase HPLC, Validation, Stability-indicating.