Analytical Purity Method Development and Validation by gas Chromatography of L-valine Methyl Ester Hydrochloride for Production of Anti-hypertensive Drugs

Abstract

Gas chromatography is the most widely used technique in pharmaceutical industry. Analytical chemistry research is largely driven by performance of sensitivity, selectivity, robustness, linear range, accuracy, precision. Validation is founded on but not specifically prescribed by regulatory requirements and is best viewed as an important and integral part of GMP (Good Manufacturing Practice). Gas chromatography method has been developed for L-valine methyl ester hydrochloride. It is used for production of anti-hypertensive drug. The Gas Chromatography system was used for method development and method validation with an auto injector and detection was performed by means of flame ionization detector (FID) with capillary column DB-624, 30m length, 0.53mm diameter and 1.0µm thickness. Nitrogen an inert gas was used as carrier gas. The method was validated for precision (system precision and method repeatability), recovery, linearity range, robustness and sample solution stability. The high recovery and low relative standard deviation confirms the suitability of the method for purity of L-valine methyl ester hydrochlride. It has been found from data of validation criteria that the proposed method has adequate reproducibility and specificity therefore suitable in pharmaceutical industry.

Key words: Validation, Gas chromatography, FID, GMP, Pharmaceutical industry.