Published Paper Details:

Gas chromatography (GC), also known as gas-liquid chromatography (GLC), is a widely utilized analytical technique in both academic and industrial research settings, particularly for quality control and the identification and quantification of components within mixtures. This paper aims to evaluate and describe the various stages involved in developing and validating GC methods. GC is recognized for its sensitivity, accuracy, repeatability, and flexibility, making it an essential tool for analyzing complex mixtures, including pharmaceuticals and medicinal compounds. However, its application is limited to molecules that can be derivatized into volatile, thermally stable compounds. The development and validation of GC methods are critical to discovering, developing, and producing pharmaceuticals. Method development involves demonstrating that an analytical technique is suitable for accurately measuring the concentration of an active pharmaceutical ingredient (API) in a specific dosage form. This allows for streamlined procedures to confirm that the method will consistently deliver precise measurements of the API in pharmaceutical preparations. The validation of these methods is crucial and is rigorously assessed for various parameters, including robustness, system suitability, linearity, accuracy, precision, range, and detection limits.