A RAPID LC-PDA METHOD FOR THE SIMULTANEOUS QUANTIFICATION OF METFORMIN, EMPAGLIFLOZIN AND LINAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM - 19/06/21
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Highlights |
• | New Stability indicating HPLC – PDA method for simultaneous quantification of Metformin, Empagliflozin, Linagliptin. |
• | Full validation of novel HPLC – PDA method as per international guidelines |
• | Rapid and economical method as it is based in shorter run time in HPLC. |
ABSTRACT |
Objective: The objective of the present study is to develop and validate a simple, rapid stability indicating high performance liquid chromatography method for the simultaneous quantification of metformin, empagliflozin, linagliptin in bulk and pharmaceutical dosage form.
Materials & methods: The chromatographic separation was achieved on C18 X-bridge phenyl column (250×4.6mm, 5µm particle size). The pharmaceutical analytes were quantified by diode array detector in HPLC, eluted with acetonitrile and triethylamine (70:30) as mobile phase, monitored at 240nm over a runtime of 7 min.
Results: The method was linear in the range of 50-750µg/ml (r2= 0.999) for metformin, 0.5-7.5 µg/ml (r2=0.999) for empagliflozin, 0.25- 3.75 µg/ml (r2= 0.999) for linagliptin. The percentage recoveries of these 3 drugs were within acceptable limits (99.2-100.8).The method was found to be precise as % RSD <2. Forced degradation studies were conducted under acidic, basic, oxidative, reductive, photolysis, thermal conditions and showed degradation within (19.4-32.4%).
Conclusion: The validated (as per ICH guidelines) rapid method can be routinely used in quality control lab for the quantification of metformin, empagliflozin and linagliptin in raw materials as well as in pharmaceutical dosage form.
Le texte complet de cet article est disponible en PDF.Keywords : RP-HPLC, Stability indicating, ICH guidelines, Metformin, Empagliflozin, Linagliptin
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