Research Journal of Pharmacy and Technology

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Development and Validation of Diclofenac Sodium in Tablets using Simple UV Spectrophotometric Method


Affiliations
1 Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
     

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An effective and simple UV-Spectrophotometric method was developed and validated for the quantification of Diclofenac sodium in tablets. The maximum absorption was found to be 282nm by using methanol as the solvent. The linearity range was 6-21 μg/ml and the correlation coefficient (r²) was found to be 0.9985. The method was accurate, precise, and robust with %RSD below 2%. The LOD and LOQ was found to be 0.0885μg/Ml and 0.250μg/mL respectively. Sandel’s sensitivity was found to be 0.000002 μg/mL. Assay and accuracy of the tablets were about of the acceptance criteria range as per the ICH guidelines.

Keywords

UV Spectrometry, Diclofenac Sodium, Tablets, Validation, ICH Guidelines.
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  • Development and Validation of Diclofenac Sodium in Tablets using Simple UV Spectrophotometric Method

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Authors

Ragini V. Mane
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
Kritika Patel
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
Gude Sai Sushmitha
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
S. G. Vasantharaju
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India

Abstract


An effective and simple UV-Spectrophotometric method was developed and validated for the quantification of Diclofenac sodium in tablets. The maximum absorption was found to be 282nm by using methanol as the solvent. The linearity range was 6-21 μg/ml and the correlation coefficient (r²) was found to be 0.9985. The method was accurate, precise, and robust with %RSD below 2%. The LOD and LOQ was found to be 0.0885μg/Ml and 0.250μg/mL respectively. Sandel’s sensitivity was found to be 0.000002 μg/mL. Assay and accuracy of the tablets were about of the acceptance criteria range as per the ICH guidelines.

Keywords


UV Spectrometry, Diclofenac Sodium, Tablets, Validation, ICH Guidelines.

References