Open AccessAnalytical Method Development and Validation for the Estimation of Canagliflozin in Bulk and Formulation by RP- HPLC
Author(s) -
Darshan Bhatt,
Padmini Thatavarthi,
B. Rajkamal
Publication year - 2018
Publication title -
international journal of pharmaceutical sciences and drug research
Language(s) - English
Resource type - Journals
ISSN - 0975-248X
DOI - 10.25004/ijpsdr.2018.100306
Subject(s) - canagliflozin , chromatography , ammonium acetate , detection limit , chemistry , elution , high performance liquid chromatography , acetonitrile , chromatographic separation , retention time , linearity , analytical chemistry (journal) , engineering , medicine , type 2 diabetes , electrical engineering , diabetes mellitus , endocrinology
A simple and sensitive reverse phase high performance liquid chromatographic method was developed and successively validated for the estimation of Canagliflozin. In the new method, Canagliflozin separation was carried out by the nonpolar inertsil ODS-3 (250 × 4.6 mm, 5μ) column with a mobile phase composition of Ammonium acetate buffer (pH-4.5) and Acetonitrile in the ratio of 30:70% v/v. Canagliflozin was determined at 252 nm using UV detection and the compound was eluted at the retention time of 4.5 min. As per International Conference on Harmonization (ICH) guidelines, the method was validated and the parameters were precision, accuracy, linearity, limit of detection, limit of quantitation and robustness. The chromatographic method was accurate, linear, specific, precise and robust. The results of method concluded that the proposed RP-HPLC method is useful, convenient and reliable in regular analysis of Canagliflozin in bulk and its formulation