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It has been developed and validated an accurate, sensitive, precise, quick, and isocratic reverse phase HPLC (RP-HPLC) technique for combined quantification of Ertugliflozin, and Sitagliptin in raw materials and pharmaceutical combined dispensing kit contains tablet dosage forms. With acetonitrile as the organic solvent, the best separation was achieved on a 250 mmx4.6 mm i.d., 5µ-particle size Hypersil®-BDS-C18 column with binary mixture of 0.03M Disodium hydrogen orthophosphate in water, adjusted to a pH of 8.5 with dilute ortho-phosphoric acid:CH3OH (55:45) (vol-by-vol) in the isocratic mode of elution as mobile phase solvent at a speed of 1.0 mL.min−1. UV detection was at 213-nm. Ertugliflozin's was 3.3 minutes, and Sitagliptin's was 3.9 minutes. With a correlation coefficient of about 0.9999, peak-response was obtained as function of concentration over the range of 20-120 µg/mL for Sitagliptin and 3-18 µg/mL for Ertugliflozin. Ertugliflozin, and Sitagliptin were shown to have a percentage assay of 99.33, and 99.38, respectively. Ertugliflozin, and Sitagliptin each have a limit of detection of 0.3 mcg/mL and 5 mcg/mL, respectively. Ertugliflozin, and Sitagliptin each have a limit of quantification (LOQ) of 0.9 mcg/mL and 15 mcg/mL, respectively. The presence of excipients in the formulation had no effect on the assay method. The procedure is appropriate for use in QC- laboratories since it is quick and precise.
Keywords:
Ertugliflozin, Sitagliptin, Isocratic-RP-HPLC, and Fixed dosage forms
Cite Article:
"Simultaneous Estimation of Ertugliflozin and Sitagliptin in Tablet dosage forms by Isocratic RP-HPLC ", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 6, page no.1084 - 1090, June-2023, Available :http://www.ijrti.org/papers/IJRTI2306160.pdf
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ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator