Analytical lifecycle management approach: Application to development of a reliable LC method for estimation of lacidipine

Abstract

Lack of quality analytical methods with assured robustness and reliability has always been a serious concern for drug regulatory agencies. In the present study, a contemporary approach of analytical life‐cycle management resulted in the robust and reliable chromatographic analysis of lacidipine at a retention time of 5.1 min on a C‐18 column. Method variables such as %acetonitrile, flow rate, and pH were optimized using the design of experiment approach and their effect on critical quality attributes was studied. The attributes of the present study were significantly influenced by %acetonitrile and flow of the mobile phase. The newly optimized method was validated for various parameters with values in accordance with federal guidance. The lifecycle approach proved to be beneficial for routine application with a potential of future bio‐analytical utility.

Chemometrics‐assisted development of a liquid chromatography method for estimation of lapatinib in tablets: A case study on a novel quality concept

“…The fundamental risk assessment and management includes use of cause‐effect diagrams and risk ranking according to risk priority number (RPN) score obtained using a Failure Mode and Effect Analysis (FMEA). Post establishment of various method variables responsible for different failure modes, design of experiments (DoE) can be applied for optimizing the method robustness‐cum‐performance and address the method challenges .…”