A Review on Analytical Method Development and Validation by Using Rp-HPLC

Chromatography is primarily a separation technique, but it is primarily used in chemical analysis. High-performance liquid chromatography (HPLC) is a highly versatile technique that separates analytes by passing them through a column packed with micron-sized particles. Today, reversed-phase chromatography is the most commonly used separation technique in HPLC. Reversed-phase chromatography is used for both analytical and preparative applications in the field of biochemical separation and purification. Moderately hydrophobic molecules such as proteins, peptides and nucleic acids can be separated by reversed-phase chromatography with excellent recovery and resolution. As a result, it has become an integral part of the requirements of the regulatory organization. Analytical method development finally results in official test methods. These methods are used in quality control laboratories to ensure the identity, purity, safety, efficacy and performance of drug products. Regulatory authorities are placing greater emphasis on analytical methods in manufacturing. Drug approval by regulatory authorities requires the applicant to prove control of the entire process of drug development by using validated analytical methods.