Volume : 13, Issue : 10, October – 2026
Title:
METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TIRZEPATIDE IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORMS BY HPLC
Authors :
E. Sushma*, Alijerla Navya, Lakavath Navyasri, Karankote Preethi, Giri Neha, Kummari Navya
Abstract :
A simple, rapid, specific and accurate reverse phase high performance liquid chromatographic method has been developed for the validated of Tirzepatide in bulk as well as in marketed pharmaceutical dosage form. This separation was performed on a Develosil ODS C18 (4.6mm×250mm, 5µm) column with Acetonitrile: Phosphate Buffer (45:55%) v/v as mobile phase at a flow rate of 1.0 mL min−1 with UV detection at 235 nm; the constant column temperature was Ambient. The run time under these chromatographic conditions was less than 8 min. The retention time of Tirzepatide was found to be 2.293min. The calibration plot was linear over the concentration range of 6–14 μg mL−1 with limits of detection and quantification values of 1.2 and 3.6 ng mL−1 respectively. The mean % assay of marketed formulation was found to be 99.86%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%.The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Tirzepatide in bulk and marketed pharmaceutical dosage form dosage form.
Keywords: Tirzepatide, RP-HPLC, Method Development, Validation, ICH Guidelines.
Cite This Article:
Please cite this article in press E Sushma et al., Method Development And Validation For The Estimation Of Tirzepatide In Bulk And Marketed Pharmaceutical Dosage Forms By HPLC.,. Indo Am. J. P. Sci, 2026; 13(10).
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