RP-HPLC Method Development and Validation for the Estimation of Trelagliptin in Pure and Pharmaceutical Dosage Form
International Journal of Science and Research (IJSR)

International Journal of Science and Research (IJSR)
Call for Papers | Fully Refereed | Open Access | Double Blind Peer Reviewed

ISSN: 2319-7064


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Research Paper | Pharmacy | India | Volume 13 Issue 7, July 2024 | Popularity: 4.8 / 10


     

RP-HPLC Method Development and Validation for the Estimation of Trelagliptin in Pure and Pharmaceutical Dosage Form

Shaik Naazneen


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


Edition: Volume 13 Issue 7, July 2024


Pages: 1400 - 1404


DOI: https://www.doi.org/10.21275/SR24724171645


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Shaik Naazneen, "RP-HPLC Method Development and Validation for the Estimation of Trelagliptin in Pure and Pharmaceutical Dosage Form", International Journal of Science and Research (IJSR), Volume 13 Issue 7, July 2024, pp. 1400-1404, https://www.ijsr.net/getabstract.php?paperid=SR24724171645, DOI: https://www.doi.org/10.21275/SR24724171645

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