Abstract

Dhirendra Kumar Mehta*, Mahato Ashok Kumar, Koiri Sonali

ABSTRACT

HPLC is the most commonly used separation technique for detecting, separating, and quantifying drugs. To optimize the method, several chromatographic parameters were investigated, including sample pretreatment, mobile phase selection, column selection, and detector selection. The purpose of this article is to go over the method development, optimization, and validation processes. Because of its advantages such as rapidity, specificity, accuracy, precision, and ease of automation, the HPLC method can be used to analyze the majority of drugs in multicomponent dosage forms. HPLC method development and validation are critical in new drug discovery, development, and manufacturing, as well as a variety of other human and animal studies. Validation of analytical methods is required during drug development and manufacturing to ensure that these analytical methods are fit for their intended purpose. To meet GMP requirements, pharmaceutical industries should have an overall validation policy that details how validation will be carried out. This article is primarily concerned with the optimization of HPLC conditions.