RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation

Background: A combination of fixed-doses containing 0.5 mg lobeglitazone sulfate and 1000 mg metformin hydrochloride has demonstrated efficacy in enhancing glycemic control in diabetes. Aim: The projected work aimed to establish and validate a high-performance thin-layer chromatographic methodology for the quantification of both drugs in tablet formulations. Objective: The task involves creating and validating a method in accordance with ICH guidelines to quantify two particular drugs in tablet formulations accurately. Methods: The high-performance thin-layer chromatographic analysis utilized aluminum plates layered with silica gel 60F254, and the solvent system consisted of acetonitrile, 1 M ammonium acetate (methanol), toluene, and triethyl amine (1.5:2.5:4:0.2 v/v/v/v), followed by densitometric scanning at 237 nm. Results: The methodology exhibited linearity in the range of 100-1500 ng/band for lobeglitazone sulfate and 1000-15000 ng/band for metformin hydrochloride, with correlation coefficients of 0.9991 and 0.9992, correspondingly. Exceptional sensitivity was observed, with detection limits of 8.17 ng/band for lobeglitazone sulfate and 271.34 ng/band for metformin hydrochloride, along with quantification limits of 24.75 ng/band for lobeglitazone sulfate and 822.24 ng/band for metformin hydrochloride. The method demonstrated precision (% relative standard deviation of peak area <360;2) and accuracy (recovery between 96 and 103%). Conclusion: The suggested methodology is fit for the concurrent quantification of both drugs in tablet formulations, making it applicable for routine quality control assessments in laboratories.

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Simultaneous Method Development and Validation of Combined Dosage Form Dapagliflozin and Vildagliptin in Bulk and Combined Tablet Dosage Form by Uv Spectrophotometer

2024

Asian J Pharm Clin Res

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Objectives: In the present work on the determination of dapagliflozin and vildagliptin in tablet dosage form, a simple, rapid, inexpensive, accurate, and precise stability-indicating ultraviolet (UV) method was established. For the measurement of vildagliptin and dapagliflozin in tablet dosage form. Methods: A UV-visible spectrophotometric technique was done. Double-distilled water was used as the dapagliflozin’s diluent. Vildagliptin’s diluent was 0.1 N NaOH. The diluent used in the dosage form that contains both vildagliptin and dapagliflozin was 0.1 N NaOH. This approach was verified for linearity, accuracy, precision, QL, and detection limit (DL). Results: For the dosages of dapagliflozin and vildagliptin (0.16:1.6–2.2:22 μg/mL), linearity were seen. Vildagliptin and dapagliflozin were found to have QLs of 3.7432 μg/mL and 1.2860 μg/mL, respectively. Vildagliptin and dapagliflozin were found to have DLs of 1.2352 and 0.4244, respectively. The developed method for estimating the dosage of dapagliflozin and vildagliptin in tablet form was proven to be accurate, exact, and quick. Under identical circumstances, the medication was stressed by hydrolysis, oxidation, photolysis, and thermal deterioration. The UV-visible system was used to analyze the stress sample. Conclusion: The proposed method was found to be simple, precise, accurate, and reproducible and can be used for routine analysis of dapagliflozin and vildagliptin in bulk and tablet dosage forms.

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RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation

Cited by 4 publications

References 21 publications

A surfactant-based quasi-hydrophobic deep eutectic solvent for dispersive liquid-liquid microextraction of gliflozins from environmental water samples using UHPLC/fluorescence detection

A surfactant-based quasi-hydrophobic deep eutectic solvent for dispersive liquid-liquid microextraction of gliflozins from environmental water samples using UHPLC/fluorescence detection

Synchronized Assessment of Lobeglitazone Sulfate and Metformin Hydrochloride in Tablet by Robust, High-performance Thin-layer Chromatographic Method

Simultaneous Method Development and Validation of Combined Dosage Form Dapagliflozin and Vildagliptin in Bulk and Combined Tablet Dosage Form by Uv Spectrophotometer

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