Investigation of Drug-Excipient Compatibility Studies Using Validated RP-HPLC Method for Azelnidipine and Telmisartan Tablets

Aims: The Drug-Excipient compatibility testing was conducted at an early product development stage to determined that Excipients were compatible with drugs used in formulation and to distinguish as many degradation products as possible using validated gradient RP-HPLC method.

Study Design: Drug-Excipient Compatibility study was conducted in glass vials at different stability conditions namely, at 300C + 20C/75% + 5% RH, 400C + 20C/ 75% + 5% RH for 04 weeks and another set of closed vials were stored in stability chamber at temperature 600C + 20C for 02 weeks.

Methodology: Samples were analyzed by validated RP-HPLC method using Inertsil C-18 Column 150 × 4.6 mm ×5 µm, column oven temperature 40°C, flow rate 1.5 mL/min, Injection volume 10 µL with run time 12.0 minutes at 254 nm using Acetonitrile and buffer as mobile phase in gradient mode.

Results: The developed method meets all system suitability parameters and found specific to determine the drug in the presence of Excipient as no interference was observed at the Retention time (Rt) of analyte.

Conclusion: There was no physical and chemical incompatibility observed with Drug-Excipient and did not observe significant increase in the related substances.