Dhwani Shah* and Rajshree Mashru

Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, India

*Corresponding Author: Dhwani Shah, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, India.

Received: January 19, 2026; Published: February 05, 2026

Abstract

Cleaning validation is a critical requirement in pharmaceutical manufacturing to prevent cross-contamination when multiple drug products are produced using shared equipment. The present study describes the development and validation of a rapid, simple, and cost-effective UV spectrometric method for the cleaning validation of Iguratimod, an anti-rheumatic agent, on various pharmaceutical equipment material surfaces. The method was developed using methanol as the diluent and validated in accordance with the International Council for Harmonisation (ICH) guideline Q2(R2).

Iguratimod exhibited maximum absorbance at 257 nm, and the method demonstrated linearity over a concentration range of 2–12 μg/mL with an excellent correlation coefficient (R² = 0.9992). The method showed high specificity with no interference from blank or excipients. Precision studies, including repeatability and intermediate precision, demonstrated relative standard deviation values below 2%. The limit of detection and limit of quantification were found to be 0.39 μg/mL and 1.20 μg/mL, respectively [5]. Accuracy was assessed through recovery studies performed at 80%, 100%, and 120% of the limit of quantification level on stainless steel (SS-316), borosilicate glass, and high-density polyethylene surfaces, yielding recoveries within the acceptable range of 96.22% to 99.15%.

The developed method was successfully applied to the assay of Iguratimod in marketed tablet formulations, with assay values ranging from 98.47% to 99.94%. Solution stability studies confirmed the stability of both standard and sample solutions under room temperature and refrigerated conditions. The validated UV spectrometric method is specific, sensitive, reproducible, and suitable for routine cleaning validation of Iguratimod in pharmaceutical manufacturing environments.

Keywords: Iguratimod; Cleaning Validation; UV Spectrophotometry; Method Validation; Swab Recovery; Pharmaceutical Equipment

References

Citation

Citation: Dhwani Shah and Rajshree Mashru. “Development and Validation of a Rapid UV Spectrometric Method for Cleaning Validation of Iguratimod on Diverse Pharmaceutical Equipment Surfaces". Acta Scientific Pharmaceutical Sciences 10.2 (2026): 35-46.

Copyright

Copyright: © 2026 Dhwani Shah and Rajshree Mashru. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.