ABSTRACT

Dapagliflozin propanediol monohydrate (DAPA), Linagliptin (LINA) and Metformin Hydrochloride (METF) is a fixed-dose combination administered to patients with diabetes mellitus to improve glycemic control. A novel spectroscopic technique; Double Divisor Ratio Spectra Derivative method (DDRSD) was developed and validated for the concurrent analysis of DAPA, LINA and METF without prior separation. This approach involves dividing the absorbance spectra of the ternary blend by the summation of the absorbance spectra of 2 out of 3 components, resulting in the generation of ratio spectra, which is subsequently subjected to the first derivative. The analyte was estimated at minima for DAPA (282 nm) and LINA (316.74 nm) and at maxima for METF (236 nm). The proposed approach was validated as per ICH guideline. Linearity was demonstrated over the range 0.5 - 25 ?g/ml, 0.2 - 14 ?g/ml and 5 - 50 ?g/ml for DAPA, LINA and METF with correlation coefficients of 0.9996, 0.9991 and 0.9994 correspondingly. The percent recoveries were in the range of 98.6 – 101 % for DAPA, 99.3 – 101.3 % for LINA and 100.3 – 101 % for METF. The percent RSD for precision was less than 2. A novel simple, precise and accurate UV spectroscopic method was established and validated for the simultaneous analysis of DAPA, LINA and METF in a synthetic mixture. This approach can besuccessfully employed for concurrent QC analysis of DAPA, LINA and METF in synthetic mixture and dosage form. Keywords: Dapagliflozin propanediol monohydrate, Linagliptin, Metformin Hydrochloride, Double divisor ratio spectra derivative
Publication date: 01/10/2025

https://ijbpas.com/pdf/2025/October/MS_IJBPAS_2025_9459.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.10.9459