Analytical method development and validation of olmutinib bulk drug as per ICH Q2 guidelines by using RP-HPLC Method

  • BALU KHANDARE Kasturi Shikshan Sanstha College of Pharmacy Shikrapur Pune, Maharashtra,India-412208
  • Atish C. Musle
  • Sanket S. Arole
  • Pravin V. Popalghat

Abstract

RP-HPLC is fast, simple, sensitive, precise, and reproducible (liquid chromatography) method, developed and validated to analyseolmutinib bulk dosage form. Using C-18 HPLC column separation was carried out. This was maintained at ambient temperature. During separation mobile phase consist of methanol (100 v/v) was delivered at a rate of 1mL/min. Using UV detector analysis was carried out at the wavelength 267.68 nm. RP-HPLC method was validated by using various parameters like, precision, limit of quantitation (LOQ), linearity and robustness. The RP-HPLC method was found to be linear over the concentration ranges from 50-100 μg/mL (r2 =0.999). Retention time for bulk olmutinib was found to be 9.349 min. LOQ of method was 5.8540 μg/mL and LOD 3.0536μg/mL. Thus, the developed RP-HPLC method was found to be robust and rugged which can be applied for the regular analysis of olmutinib in the bulk as well as pharmaceutical dosage form.


Keywords: C18, RP-HPLC, Methanol, Olmutinib

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KHANDARE B, Musle AC, Arole SS, Popalghat PV. Analytical method development and validation of olmutinib bulk drug as per ICH Q2 guidelines by using RP-HPLC Method. JDDT [Internet]. 30Aug.2019 [cited 24Oct.2020];9(4-A):608-11. Available from: http://www.jddtonline.info/index.php/jddt/article/view/3527