Analytical Method Development and Validation for the Quantification of Bromofenac Sodium Sesquihydrate in Bulk and Its Formulation by Gaussian Distribution and Area Under the Curve Spectrophotometric Methods
Kothapalli Bannoth Chandra Sekhar1*, S. Sravani2, S. Muneer2, A. Saritha2, B. Lakshmi Prasanna2, R. Sai Srujana2
1Professor and Director, Department of Chemistry, JNTUA-Oil Technological and Pharmaceutical Research Institute, Jawaharlal Nehru Technological University Anantapur (JNTUA), Ananthapuramu-515002, A.P., India.
2Department of Pharmaceutical Sciences, JNTUA-Oil Technological and Pharmaceutical Research Institute, Jawaharlal Nehru Technological University Anantapur (JNTUA), Ananthapuramu-515002, A.P., India.
The aim of the present work was to determine the validation characteristics for the developed methods of the quantification of Bromofenac Sodium Sesquihydrate (BFS) by absorption spectrophotometry. The method is based on Gaussian distribution (Zero, First and Second Order) and Area under the Curve (AUC) method. The entire study was explained in four methods which includes three gaussian methods i.e., Zero order (Method 1), First order (Method 2), Second order (Method 3) and other was AUC (Method 4) spectroscopy. Methanol was used as a diluent for all the methods. The amplitudes for the three Gaussian distribution methods were measured at wavelengths of 260 nm (Method 1), 257.5 nm (Method 2) and 241.5 nm (Method 3) respectively. AUC (Method 4) was studied at the integrated areas of 256 and 266 nm. The developed methods showed linearity in the range of 2-12 µg/ml. The correlation co-efficient was found to be ≥ 0.999 and the results from all the spectrophotometric methods proved that the technique developed by us is accurate, reproducible and meets the current requirements.
Key words: Bromofenac Sodium, Gaussian distribution, AUC, Validation.