A Study of Analytical Method Development and Validation for Quantitative Analysis of Paracetamol by using UV Spectroscopy

Abstract

Analytical process development and validation is essential for quantitative analysis of pharmaceutical products to maintain their quality, safety and efficacy. Ultraviolet (UV) spectroscopy is a widely used technique for the analysis of pharmaceutical substances due to its simplicity, sensitivity and ability to provide rapid results .UV spectroscopy is chosen due to its ability to detect compounds or drugs based on their absorption of ultraviolet light typically within the range of 200-400nm.Additionally the method is validated for accuracy , precision, specificity and reproducibility to meet regulatory standards. All the validation parameters were chosen according to ICH guidelines for analysis of any compound. An UV spectrophotometric method has been established for the quantitative analysis of paracetamol in tablet dosage forms.

Introduction

UV-visible (UV-Vis) spectroscopy is a common analytical technique used for both qualitative and quantitative analysis of chemical and pharmaceutical compounds by measuring their absorption of UV or visible light. This method provides insights into molecular structure, concentration, and purity.

The International Conference on Harmonisation (ICH) guidelines define key validation parameters for analytical methods, such as accuracy, precision, specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), and robustness, ensuring methods deliver reliable and reproducible results.

A UV-Vis spectrophotometric method was developed and validated for quantifying paracetamol in tablet formulations, using a water-ethanol mixture as diluent. The method involves preparing standard and sample solutions, scanning paracetamol between 200–400 nm (with maximum absorbance at 243 nm), and applying Beer-Lambert law for quantification.

Key findings from method validation include:

• Accuracy: Recovery rates between 98.64% and 99.11%, indicating the method is accurate.

• Precision: Repeatability and intermediate precision tests showed %RSD values below 2%, confirming reproducibility.

• Linearity: The method demonstrated excellent linearity (R² = 0.9998) across concentrations from 50 to 150 µg/mL.

Paracetamol, an analgesic and antipyretic widely used to relieve mild to moderate pain and fever, is rapidly absorbed and metabolized primarily in the liver. The developed UV-Vis method offers a simple, reliable tool for routine quantitative analysis of paracetamol in pharmaceutical tablets.

Conclusion

For the assay of paracetamol , this validation method is developed . By using UV spectroscopy this method was successfully validated for accuracy, precision, linearity, and robustness as per ICH guidelines. The method demonstrated strong linearity over the selected concentration range, excellent precision with %RSD < 2%, and high accuracy with recovery rates close to 100% and rodust.So concluded that this analytical method can be used for intended purpose .

References

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Copyright

Copyright © 2025 Esika Mondal , Indrani Biswas, 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.