A simple, stability indicating high performance liquid chromatographical (HPLC) method was
developed 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 and
acetonitrile (60:40 v/v) running at a rate of 1 mL/min and monitoring effluents at 230 nm. The retention
time 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 of
empagliflozin 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 indicate
the 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 of
empagliflozin and linagliptin in solid dosage forms.
The development and validation of the modality for quantitative amoxicillin assay in solid dosage forms by means of FTIR spectroscopy
