Volume : 13, Issue : 09, September – 2026
Title:
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF ETELCALCETIDE IN BULK AND MARKETED PHARMACEUTICAL FORMULATION
Authors :
Prashanthi Gali *, B.V.N.S. Jaya Lahari , Ratnam Sarayu, G. Usha Laxmi , P. Venu
Abstract :
A simple, rapid, specific and accurate reverse phase high performance liquid chromatographic method has been developed for the validated of Etelcalcetide in bulk as well as in marketed pharmaceutical dosage form. This separation was performed on a Symmetry ODS C18 (4.6mm×250mm, 5µm) column with Methanol: Phosphate Buffer (35:65%) 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 Etelcalcetide 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 Etelcalcetide in bulk and marketed pharmaceutical dosage form dosage form.
Keywords: Etelcalcetide, RP-HPLC, Method Development, Validation, ICH Guidelines.
Cite This Article:
Please cite this article in press Prashanthi Gali et al., Development And Validation Of Rp-Hplc Method For The Estimation Of Etelcalcetide In Bulk And Marketed Pharmaceutical Formulation.,. Indo Am. J. P. Sci, 2026; 13(09).
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