Method Development & Validation of Diclofenac Sodium and Pantoprazole

The present work describes various methods for the simultaneous estimation of Diclofenac sodium (DICLO) and Pantoprazole (PANTO) in combined Capsule dosage form. A simple, accurate and reproducible RP-HPLC method have been developed and validated for the simultaneous estimation of Diclofenac sodium and Pantoprazole in their marketed formulation. The RP-HPLC methods were validated by Stastically. The retention times of Diclofenac sodium and Pantoprazole were found to be 3.33 ± 0.10 min and 6.66 ± 0.10 min, respectively. Linearity was evaluated over the concentration range of 18.75-56.25 µg/ml for DICLO and 5-15 µg/ml for PANTO by RP-HPLC method. The correlation coefficient and accuracy of both the methods were found to be within the range. The % RSD of precision was found to be NMT 2.0 % for HPLC method. The proposed methods were found to be robust when slight but deliberate changes were made in analytical conditions. Simple, accurate and reproducible RP-HPLC method were developed and validated for the simultaneous estimation of Diclofenac sodium and Pantoprazole in their marketed formulation. The proposed methods can be applied for the routine analysis in quality control laboratory.