Open AccessDevelopment and Validation of a Stability-Indicating HPLC Method for Empagliflozin and Linagliptin in Tablet Dosage Form
Author(s) -
Wael Abu Dayyih,
Israa Al Ani,
Ramadan AlShdefat,
Zainab Zakareia,
Sarah Hamid,
Ashok K. Shakya
Publication year - 2021
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2021.23019
Subject(s) - empagliflozin , linagliptin , chemistry , chromatography , high performance liquid chromatography , dosage form , type 2 diabetes , diabetes mellitus , medicine , endocrinology
A simple, stability indicating high performance liquid chromatographical (HPLC) method wasdeveloped and validated for the estimation of empagliflozin and linagliptin in combined dosage forms.Chromatographical separation was optimized by isocratic HPLC using C-18 column [BDS 250 mm ×4.6 mm, 5 μm] utilizing a mobile phase consisting a mixuture of 0.1% orthophosphoric acid andacetonitrile (60:40 v/v) running at a rate of 1 mL/min and monitoring effluents at 230 nm. The retentiontime of empagliflozin and linagliptin was 2.05 min and 4.10 min, respectively. Correlation coefficient(r2) was 0.999 for both empagliflozin and linagliptin. The precision of method for the analysis ofempagliflozin and linagliptin were 0.33 and 0.22, respectively. The accuracy of method (as recovery)was 100.96 to 101.48% for empagliflozin and 100.09 to101.13% for linagliptin. The results indicatethe present method is accurate, precision and rugged as these results are within the specified limits.Therefore, the validated economical methodology can be applied for forced degradation study ofempagliflozin and linagliptin in solid dosage forms.