Abstract

Dr. Mona R. Patel*, Dr. Ojas B. Patel, Mr. Keyur Patel, Mr. Rahul Mahakal, Mr. Shailesh Jadav, Mr. Chirag Birari, Mr. Brijesh Patel

ABSTRACT

Objective: The primary goal of this study is to use the colorimetric approach to estimate the dosage of Diclofenac potassium in tablet dosage form. The developed approach has been validated in accordance with ICH Q2(R2) requirements. Methods and materials: Chromatographic quantification was performed with a detection wavelength of 540 nm and a concentration range of 5-25 µg/ml. Diclofenac potassium was shown to have a correlation coefficient of 0.992. Result: Diclofenac potassium's regression equation was determined to be y = 0.030x + 0.385. Diclofenac potassium's detection limit (DL) and quantitation limit (QL) were determined to be 0.544 μg mL-1 and 1.650 μg mL-1, respectively. In accordance with ICH Q2(R2) criteria, the developed method was validated. For both the system and intermediate precision, the percentage RSD was under 2%. Diclofenac potassium recovery was found to be over 99%. Conclusion: The results show that the developed method is simple, reliable and cost-effective, making it suitable for quality control of Diclofenac potassium in tablets.