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Research Paper | Pharmacy | Volume 13 Issue 7, July 2024 | Pages: 1400 - 1404 | India
RP-HPLC Method Development and Validation for the Estimation of Trelagliptin in Pure and Pharmaceutical Dosage Form
Abstract: An accurate, sensitive, precise, simple isocratic reverse phase HPLC (RP-HPLC) method has been developed and validated for quantification of Trelagliptin in bulk and pharmaceutical tablet dosage forms. With acetonitrile as the organic solvent, the best separation was achieved on a 250 mmx 4.6 mm i.d, 5?-particle size Inertsil?-Octadecyl-silyl-3V-Reverse-Phase-C18-column with 0.02M Dipotassium hydrogen orthophosphate in water pH: 2.5 with Orthophosphoric acid: Acetonitrile (40:60v/v) in the isocratic mode of elution as mobile phase solvent at a speed of 1.0 ml/ min. UV detection was at 210 nm. Retention time of Trelagliptin was 12.8 minutes. With a correlation coefficient of about 0.9974, peak-response was obtained as function of concentration over the range of 80 to 240 ?g/ ml for Trelagliptin. Trelagliptin was shown to have a percentage assay of 110.89 %. Trelagliptin had a limit of detection (LOD) of 0.2 ?g/ mL and a limit of quantification (LOQ) of 0.6 ?g/ ml. The presence of excipients in the formulation Zafatek had no effect on the assay method. The procedure is appropriate for use in QC- laboratories since it is economical and precise.
Keywords: Trelagliptin, Zafatek, RP-HPLC, Isocratic, Dipotassium hydrogen Orthophosphate
How to Cite?: Shaik Naazneen, "RP-HPLC Method Development and Validation for the Estimation of Trelagliptin in Pure and Pharmaceutical Dosage Form", Volume 13 Issue 7, July 2024, International Journal of Science and Research (IJSR), Pages: 1400-1404, https://www.ijsr.net/getabstract.php?paperid=SR24724171645, DOI: https://dx.doi.org/10.21275/SR24724171645