Volume 19, Issue 44, July - December, 2025

Stability indicating high performance thin layer chromatography method development and validation of Trifluoperazine in bulk and tablet dosage form using a QbD apporach

Shweta R Bharati¹, Madhuri S Nalawade¹, Kumudini R Pawar^1♦

¹Abhinav Education Society’s College of Pharmacy (B. Pharm), Narhe, Pune, 411041, India

^♦Corresponding author
Dr. Kumudini R Pawar, Abhinav Education Society’s College of Pharmacy (B. Pharm), Narhe, Pune, 411041, Maharashtra, India

ABSTRACT

This research emphasizes use of quality by design framework in conducting a qualitative assessment of Trifluoperazine in both its bulk and tablet forms, with the subsequent development and validation of a high-performance thin layer chromatography technique. Chromatographic separation was performed using thinlayer chromatography on aluminium silica gel 60 F254 plates, employing a mobile phase composed of methanol, ethyl acetate, and ammonia in a volumetric ratio of 9:1:0.2. Densitometric analysis is conducted at a wavelength of 303 nm, and the Rf value for trifluoperazine was determined to be 0.38. The method demonstrated a high degree of linearity (r²= 0.9956). The process is optimized by evaluating the impact of critical method variables such as mobile phase composition and saturation time on chromatographic performance. Therefore, the previously mentioned parameters are subsequently refined utilizing the central composite design methodology, with the Rf value identified as the critical analytical attribute. The methodology is rigorously validated for parameters such as linearity, accuracy, precision, robustness, and sensitivity, with the limits of detection and quantitation showing favourable results. The validation process conformed to the standards established by the International Conference on Harmonization and met the required criteria. Consequently, this research illustrates the effective implementation of Quality by Design in formulation of superior high performance thin layer chromatography technique that integrates accuracy, reliability, and efficacy, along with system assurance and methodological robustness.

Keywords: Trifluoperazine, QbD, HPTLC, Analytical Method Development, Design of Experiments (DoE), Central Composite Design

Drug Discovery, 2025, 19(44), e17dd2097

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Published: 29 August 2025