Stability Indicating Analytical Method Development and Validation for the Estimation of Calcium Dobesilate in Bulk Drug Using RP-HPLC

Abstract

Introduction: The aim of the study is to develop a simple, precise, accurate, linear, and rapid stability-indicating
method for the separation and identification of degradation products and mass studies of calcium dobesilate (CAD)
drugs used in the treatment of diabetic retinopathy and chronic kidney disease as per the International Conference
on Harmonization’s (ICH) guidelines. Materials and Methods: The technique makes use of an isocratic mode,
an Enable C18 Kromasil (250 × 4.6 mm; 5μ) column, and a reverse phase column. The optimal parameters for
the method are the mobile phase of acetonitrile (0.1%), OPA in water (20:80), a flow rate of 1 mL/min, and a
UV detector with a detection wavelength of 310 nm. Results and Discussion: Degradation was carried out and
CAD was sensitive to base conditions. Structure elucidation of the forced degradation products was observed
using liquid chromatography-mass spectrometry. CAD was found to be stable under thermal, photolytic, acid, and
peroxide conditions. Two degradation products were reported, but we did not get the m/z of degradation products
of CAD. We report these degradation products as unknown impurities. The suggested procedure was validated
in accordance with ICH Q2 (R1) standards. Accuracy studies were observed that the percentage recovery was
found to be 98.0–102.0% and the linearity of the method was excellent over the range of 80–120 μg/mL. Relative
standard deviations of 0.612% demonstrate the precision. The results showed that the limits of detection and
quantitation were, respectively, 0.477 and 1.445 ug/mL. Conclusion: According to validation and degradation
results, the method was found to have good stability, indicating its nature as well as being user-friendly