Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND TENELIGLIPTIN HYDROBROMIDE HYDRATE FROM SYNTHETIC MIXTURE BY THREE DIFFERENT UV SPECTROPHOTOMETRIC METHODS

Anokhi Patel*, Preeti Jadeja and Dr. Rajashree Mashru

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Abstract

Three new UV spectrophotometric methods namely simultaneous equation, Q-absorbance ratio and first derivative (zero crossing) spectroscopic methods were developed and validated for simultaneous estimation of Dapagliflozin and Teneligliptin hydrobromide hydrate which were simple, sensitive, precise and accurate. In simultaneous equation method, absorbance was measured at 223 and 243 nm for both the drugs. Dapagliflozin and Teneligliptin hydrobromide hydrate hydrochloride showed an iso-absorptive point at 230 nm in Qabsorbance ratio method. The second wavelength used was 223 nm which is λ max of Dapagliflozin in distilled water. First derivative (zero crossing) method was based on the transformation of UV spectra in to first derivative spectra followed by measurement of first derivative signal at 223 and 243 nm for Dapagliflozin and teneligliptin hydrobromide hydrate, respectively using 2 nm as wavelength interval (Δλ) and 1 as scaling factor. Developed methods were validated according to ICH guidelines including parameters viz., specificity, linearity and range, precision, accuracy, limit of detection and quantification. All the three methods showed linear response in the concentration range of 5-75 μg/ml for both the drugs. Results of method validation parameters follows ICH guideline acceptable limits. Based on the assay results obtained, methods were compared using one-way ANOVA. Methods were found to be simple, fast, highly sensitive, cost effective and hence can be useful for simultaneous estimation of Dapagliflozin and teneligliptin hydrobromide hydrate which showed good applicability of the developed method.

Keywords: Dapagliflozin (DAPA) Teneligliptin (TEN) simultaneous equation, Q-absorbance ratio, first derivative (zero crossing) spectroscopic methods.