Pharmaceutica Analytica Acta

Validation and Comparison of Drug Analysis Techniques and Chromatographic Methods

Wenriohan Chang^* Department of Pharmaceutical Analysis, Shanghai University, Shanghai, China
^*Correspondence: Wenriohan Chang, Department of Pharmaceutical Analysis, Shanghai University, Shanghai, China, Email:

Received: 02-Jun-2023, Manuscript No. PAA-23-22072; Editor assigned: 05-Jun-2023, Pre QC No. PAA-23-22072(PQ); Reviewed: 19-Jun-2023, QC No. PAA-23-22072; Revised: 26-Jun-2023, Manuscript No. PAA-23-22072(R); Published: 03-Jul-2023, DOI: 10.35248/2153-2435.23.14.737

Description

Drugs and their metabolites are often measured in biological samples such as blood, urine, saliva, or tissue to monitor pharmacokinetics, pharmacodynamics, efficacy, safety, or drug interactions. The choice of the analytical method depends on various factors such as the nature of the analyte, the matrix, the required sensitivity, specificity, accuracy, precision, and throughput. The analytical method should be validated to demonstrate that it is suitable for its intended purpose and meets the predefined acceptance criteria. The validation parameters include selectivity, linearity, range, accuracy, precision, recovery, matrix effect, stability, and robustness. The validation process should follow the relevant guidelines and regulations from the International Council for Harmonization (ICH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other authorities.

The most common analytical methods for the detection and quantification of drugs and their metabolites in biological samples are chromatographic techniques coupled with Mass Spectrometry (MS) or optical detectors. Chromatographic techniques separate the analytes from the matrix components based on their physicochemical properties and interactions with the stationary and mobile phases. MS provides high sensitivity, selectivity, and structural information by ionizing the analytes and measuring their mass-to-charge ratios.

Some of the advantages and disadvantages of different chromatographic techniques

Gas Chromatography (GC): It is suitable for volatile and thermally stable analytes. It requires derivatization for polar or thermally labile analytes. It offers high resolution, speed, and sensitivity. It can be coupled with Flame Ionization Detector (FID) for detection.

High-Performance Liquid Chromatography (HPLC): It is suitable for a wide range of analytes with different polarities and molecular weights. It requires sample preparation to remove proteins and other matrix components. It offers good resolution, sensitivity, and versatility. It can be coupled with MS or EC detectors for detection.

Ultra-Performance Liquid Chromatography (UPLC): It is a variant of HPLC that uses smaller particle sizes and higher pressures to achieve faster separations with higher resolution and sensitivity. It can be coupled with MS (UPLC-MS), UV, FL, or EC detectors for detection.

Capillary Electrophoresis (CE): It is suitable for charged analytes. It requires minimal sample preparation and consumes less solvent. It offers high resolution, speed, and efficiency. It can be coupled with MS or Laser-Induced Fluorescence (LIF) detectors for detection.

The comparison of analytical methods should be based on their performance characteristics such as sensitivity, selectivity, accuracy, precision, recovery, matrix effect, stability, robustness, cost, and time. The comparison should also consider the specific requirements of the study such as the type of analyte, matrix, sample size, sampling frequency, storage conditions, and regulatory standards. The comparison should be done using appropriate statistical methods such as Analysis Of Variance (ANOVA), t-test, F-test, or correlation analysis. The validation and comparison of analytical methods are essential steps to ensure the quality and reliability of the bio analytical data in support of drug development and clinical trials. The choice of the analytical method should be based on a rational evaluation of its advantages and disadvantages in relation to the study objectives and design.