Author(s):
Supriya Takalkar, Pratibha Daroi, Bhushan Sonawane
Email(s):
pratibhaadaroi@gmail.com
DOI:
10.52711/0974-360X.2026.00463 
Address:
Supriya Takalkar1, Pratibha Daroi1*, Bhushan Sonawane2
1Department of Quality Assurance, LSHGCT’s Gahlot Institute of Pharmacy, Plot no. 59, Sector-14, Koparkhairane, Navi Mumbai – 400709, Maharashtra, India.
2Analytical Research and Development, Central Drug Testing Laboratory, Zonal FDA Bhavan, GMSD Compound, Belasis Road, Mumbai Central, Mumbai – 400008, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 7,
Year - 2026
ABSTRACT:
A novel and trustworthy technique for the quantitative measurement of trifarotene in medicinal cream formulations has been developed and validated: high-performance thin-layer chromatography (HPTLC). Chromatographic analysis was performed on Silica Gel 60 F254 plates by employing a mobile phase with components like chloroform, ethyl acetate, ethanol, and formic acid in ratio of 7.5:2:0.5:0.1 (v/v/v/v). Trifarotene has been effectively separated, exhibiting an Rf value of approximately 0.55. Following the standards of ICH Q2 (R1), this method was validated by evaluating factors including specificity, linearity, precision, accuracy, sensitivity, and robustness. Within a concentration range of 2–10 µg/mL, a linear response had been seen, with a correlation coefficient of 0.9994. Average recovery was 99.83%, indicating high accuracy. As there are no prior HPTLC methods reported for this analyte in topical creams, this study offers a novel and validated approach to regularly check the quality of pharmaceutical compositions.
Cite this article:
Supriya Takalkar, Pratibha Daroi, Bhushan Sonawane. Development and ICH-Compliant Validation of a Robust HPTLC Method for Quantifying Trifarotene in Dermatological Creams. Research Journal of Pharmacy and Technology. 2026;19(7):3251-6. doi: 10.52711/0974-360X.2026.00463
Cite(Electronic):
Supriya Takalkar, Pratibha Daroi, Bhushan Sonawane. Development and ICH-Compliant Validation of a Robust HPTLC Method for Quantifying Trifarotene in Dermatological Creams. Research Journal of Pharmacy and Technology. 2026;19(7):3251-6. doi: 10.52711/0974-360X.2026.00463 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-7-50
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