Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN HYDROBROMIDE HYDRATE AND DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE IN TABLET DOSAGE FORM

Patel Shruti H.*, Dr. Vishal Modi, Dr. Minakshi Dhoru, Ms. Anju Singhal

ABSTRACT

A novel, simple, precise, and robust high-performance thin-layer chromatography (HPTLC) method was developed and validated for the simultaneous estimation of Teneligliptin Hydrobromide Hydrate (TENELI) and Dapagliflozin Propanediol Monohydrate (DAPA) in tablet dosage form. The method was optimized to achieve good separation and reproducibility with minimal sample preparation. Chromatographic separation was carried out on silica gel 60 F₂₅₄ TLC aluminum plates using a mobile phase consisting of Toluene:Methanol(7:3v/v). The developed chromatogram was scanned and quantified densitometrically at a detection wavelength of 230 nm. The Rf values for Teneligliptin and Dapagliflozin were found to be [0.45 and 0.56], indicating satisfactory separation without interference. The method was validated in accordance with ICH Q₂(R₂)guidelines, covering parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ), and robustness. The linearity was observed in the concentration range of [0.996] µg/spot for TENELI and [0.999] µg/spot for DAPA with correlation coefficients greater than 0.995 for both drugs. Recovery studies confirmed the accuracy of the method, with percent recovery between 98.0% and 102.0%. Precision studies yielded C.V. values less than 2%, indicating high reproducibility. No interference from common tablet excipients was observed, confirming the specificity of the method. The developed HPTLC method offers a cost-effective, reliable, and efficient analytical tool for routine quality control and stability testing of Teneligliptin and Dapagliflozin in combined pharmaceutical dosage forms.

Keywords: HPTLC, Teneligliptin Hydrobromide Hydrate, Dapagliflozin Propanediol Monohydrate, Method Development, Validation, Type 2 Diabetes.