Development and validation of a visible spectrophotometric method for the determination of tretinoin in bulk and pharmaceutical formulations

Manikya Sastry Thuttagunta; Ramakrishna Karipeddi; Santosh Kumar Nadikatla; Surekha Pinninti; Santhosh Kumar  Badampudi

doi:10.69857/joapr.v14i2.1279

Authors

Manikya Sastry Thuttagunta Department of Chemistry, Gayatri Vidya Parishad College of Engineering (Autonomous), Visakhapatnam– 530048, Andhra Pradesh, India
Ramakrishna Karipeddi Department of Chemistry, Faculty of Science and Technology (ICFAI TECH), ICFAI Foundation for Higher Education, Hyderabad -501203. India
Santosh Kumar Nadikatla Department of Chemistry, GMR Institute of Technology (GMRIT) - Deemed to be University, Rajam 532127, Andhra Pradesh, India
Surekha Pinninti Department of Chemistry, Government College (Autonomous), Rajamundry 533105 , Andhra Pradesh, India.
Santhosh Kumar Badampudi Department of Chemistry, Gayatri Vidya Parishad College of Engineering (Autonomous), Visakhapatnam– 530048, Andhra Pradesh, India

DOI:

https://doi.org/10.69857/joapr.v14i2.1279

Keywords:

Tretinoin, Methylene Blue, Ion-Pair Complex, Method Validation, Pharmaceutical Analysis

Abstract

Background: Tretinoin is a widely used dermatological agent, and its accurate quantification is essential for quality control in pharmaceutical formulations. Existing UV-spectrophotometric methods often lack the sensitivity and simplicity required for routine analysis. Methodology: A simple, rapid, and cost-effective visible spectrophotometric method was developed for the determination of tretinoin in bulk and 0.05% cream formulations. The method is based on the formation of a stable ion-pair complex between tretinoin and methylene blue in an alkaline medium (pH 9.8). The resulting complex exhibits maximum absorbance at 650 nm. Method validation was carried out in accordance with ICH Q2(R1) guidelines. Results and Discussion: The method showed linearity in the concentration range of 2–10 µg/mL, with a correlation coefficient (r²) of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.0434 µg/mL and 0.1316 µg/mL, respectively. Precision and accuracy results were within acceptable limits. Recovery ranges for 0.05% tretinoin cream formulations are 98.7% to 101.1%, confirming the method’s suitability for real-sample analysis. Compared to existing UV methods, this approach offers enhanced sensitivity and operational simplicity. Conclusion: The proposed spectrophotometric method is a reliable and sensitive alternative for the routine quantification of tretinoin in pharmaceutical formulations. Its simplicity, cost-effectiveness, and compliance with regulatory validation standards make it well-suited for quality control laboratories.

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