Analytical method development and validation for the quantitative estimation of trametinib in api and marketed tablet dosage form by using hplc method

Authors

  • J. Farhana Department of Pharmaceutical Analysis, Mallareddy Pharmacy College, Dhulapally, Maisammaguda, Secunderbad, Telengana, India.
  • Y. Myna Department of Pharmaceutical Analysis, Mallareddy Pharmacy College, Dhulapally, Maisammaguda, Secunderbad, Telengana, India.
  • V. Anjali Department of Pharmaceutical Analysis, Mallareddy Pharmacy College, Dhulapally, Maisammaguda, Secunderbad, Telengana, India.
  • U.Akhila sree Department of Pharmaceutical Analysis, Mallareddy Pharmacy College, Dhulapally, Maisammaguda, Secunderbad, Telengana, India.
  • V. Sai priya Department of Pharmaceutical Analysis, Mallareddy Pharmacy College, Dhulapally, Maisammaguda, Secunderbad, Telengana, India.
  • J. Praveen kumar Department of Pharmaceutical Analysis, Mallareddy Pharmacy College, Dhulapally, Maisammaguda, Secunderbad, Telengana, India.

Keywords:

Methanol, UV spectrophotometric estimation, RP-HPLC Method development, Validation.

Abstract

A Correct, particular, easy and reproducible, isocratic Reversed section high overall performance Liquid chromatography (RP-HPLC) Technique became developed and established for the simultaneous estimation of trametinib in API and marketed dosage form. Trametinib were separated through the usage of a symmetry C18 ODS (4.6mm 250mm) 5m particle size HPLC WATERS with Empower to software with Isocratic by using UV- Visible Detector. Mobile phase consist of Acetonitrile: phosphate buffer (0.01M,pH-3.2 (30:70v/v). The flow rate has become set to 1ml/min with responses measured at 246 nm. The retention time was 5.453 min. Linearity emerge with correlation coefficient is 0.999.The present method was validated as per guidelines of International conference on Harmonization (ICH) including parameters like specificity, linearity, precision, accuracy, and robustness, restriction of detection (LOD) and restrict of quantitation.

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Published

2022-09-21