Application of DoE-Based Analytical QRM to Development of the Multipurpose RP-HPLC Method for Estimation of Multiple FDC Products of Telmisartan Using Enhanced AQbD Approach.

Abstract

Telmisartan is an antihypertensive drug and several FDC products of telmisartan are available in the market for the treatment of hypertension. The multipurpose reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated as economical and eco-friendly alternative to numerous published chromatography methods for synchronous estimation of FDC of telmisartan to save time, cost and solvent for analysis. The analytical quality risk management was initiated with identification of potential method parameters using cause-effect diagram followed by assessment of their risk by risk priority number ranking and filtering method. The risk of critical method parameters was controlled by their optimization using design of experiments-based full-factorial design. The method operable design ranges was identified for high-risk method parameters, and control strategy was set for mitigation of their risk throughout the life cycle of the developed RP-HPLC method. The RP-HPLC method was validated as per the ICH Q2 (R1) guideline. The RP-HPLC method was applied for simultaneous estimation of seven FDC products of telmisartan, and results were found compliance with labeled claim. The developed RP-HPLC method is fulfilling requirements of numerous RP-HPLC and high performance thin layer chromatography methods for the said estimation. It can be used as a multipurpose RP-HPLC method for quality control of FDC products of telmisartan in the pharmaceutical industry to save solvent, cost and time of analysis.