Volume : 10, Issue : 03, March – 2023

Title:

49.DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF TRAMETINIB IN API AND MARKETED PHARMACEUTICAL TABLET DOSAGE FORM
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Authors :

Sheik Heena, Sushma Desai*, B.Chandrasekhara Rao

Abstract :

It has been developed a precise, right, rough, and precise switched fragment over the top execution fluid chromatography (RP-HPLC) technique to quantify the quantitative commitment of Trametinib in active drug parts and in its Pharmaceutical dosage structure by using the use of the C18 (four.6mm x 150m, 5m) column with the cell segment containing an Acetonitrile and Potassium dihydrogen phosphate cushion acclimated to pH-2.8 with ortho phosphoric acid in the cell section. The float charge was increased to 1.0 ml/min, gushing was seen at 246 nm, a pinnacle eluted at 4.865 minutes, and the section broiler temperature was maintained at the surrounding level. A range of 10 to 30 g/ml was indicated on the adjustment bend. Trametinib’s LOD and LOQ were reported to be 1.three and 3.9 micrograms per millilitre, respectively. There is no guarantee that the offer recovery will fall inside the cutoff thresholds. Extensiveness, LOD, LOQ, linearity, exactness, precision, middle of the road accuracy, and power were all found to be consistent with the current global gathering on Harmonization (ICH) concepts for these parameters. Trametinib typical resolution in mass medicine and its drug dosage form may be helped by the suggested RP- HPLC technique, which was shown to be easy to use, rapid, accurate, and precise. The suggested method was used to examine tablet designs for quality control and assurance of remedial feasibility, as outlined in the paper.
Keywords: Trametinib, RP-HPLC, Accuracy, Precision, Validation, and ICH.

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