Development and Method Validation for the Quantitative Estimation of Diclofenac Sodium Tablet by Spectrophotometric Method

Abstract

Spectrophotometric method is used to developed and validated for quantifying and detecting the drug diclofenac sodium. The analytical process development and validation are essential for finding the easiest way to evaluate diclofenac sodium with maintain the safety, quality and effectiveness of pharmaceutical products. Ultra Violet (UV) spectroscopy is commonly used for substance analysis in the pharmaceutical industry due to its ability to deliver quick and accurate results. The technique measures the absorption of the ultra violet light, typically between 200-400 nm, making it effective for analyzing compounds based on their UV absorption characteristics. To meet regulatory requirements, the method must be validated for parameters such as specificity, precision, accuracy, reproducibility, limit of determination (LOD), and limit of quantification (LOQ) This ensures that the technique provides reliable and consistent measurements of active pharmaceutical ingredients and excipients, following established guidelines for optimal performance and quality control. This method follows the Beer- Lambert\'s Law. Accuracy of the drug was about the acceptance criteria as per the ICH guidelines.48

Introduction

Analytical Chemistry:
Analytical chemistry focuses on identifying the components (qualitative analysis) and measuring their amounts (quantitative analysis) in a sample, using classical (older, manual) and instrumental (advanced machines) methods.

Spectroscopy:
Spectroscopy studies how light or electromagnetic radiation interacts with matter, crucial for understanding atomic and molecular structures. Optical spectroscopy covers wavelengths from 100 Å to 400 μm.

UV-Visible Spectrophotometer:
This instrument measures how much UV and visible light a substance absorbs by passing light through it. Different substances absorb light differently, enabling identification and concentration measurement. The Beer-Lambert law explains light absorption in relation to concentration and path length.

Instrumentation Components:
Key parts include a light source (deuterium for UV, tungsten-halogen for visible), monochromator (selects specific wavelengths), sample holder (quartz or glass cuvettes), detector (measures transmitted light), and data processing unit (analyzes data).

Method Development:
Involves optimizing steps, tools, and conditions to ensure accurate, reliable, and reproducible analytical results, including testing with real samples.

Method Validation:
Confirms a method’s reliability by assessing accuracy, precision, specificity, sensitivity, linearity, robustness, and detection/quantification limits.

Drug Profile - Diclofenac Sodium:
A nonsteroidal anti-inflammatory drug (NSAID) that inhibits COX enzymes to reduce pain and inflammation. It has specific chemical and pharmacokinetic properties.

Aim & Objective:
To develop and validate an analytical UV spectrophotometric method for diclofenac sodium, ensuring accuracy, precision, specificity, linearity, and robustness.

Materials & Methods:
Diclofenac sodium samples and standard solutions were prepared using methanol-water diluent. A single-beam UV-visible spectrophotometer was used with quartz cuvettes.

Results & Discussion:

• Maximum absorption wavelength for diclofenac sodium: 275 nm.

• Linearity established between 0-10 ppm concentration with good correlation.

• Precision tested via repeatability and intermediate precision with low %RSD (~0.38).

• Accuracy validated by recovery studies with 98.86–99.32% recovery, indicating high method accuracy.

Conclusion

The validated analytical method for the determination of diclofenac sodium in water was found to be accurate, precise. The method demonstrated good linearity in the range of tested concentration range. Recovery studies confirmed the accuracy of the method, while intra-day and inter-day precision results were within acceptable limits, indicating reproducibility. Overall, the validated method is reliable and suitable for routine analysis of diclofenac sodium in water samples, ensures compliance with environmental and pharmaceutical quality standards and cost effectiveness.

References

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Copyright

Copyright © 2025 Indrani Biswas, Esika Mondal, Suvojit Basak, Joydeep Karmakar, Soumallya Chakraborty, Somenath Bhattacharya. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.