GOVERNMENT INITIATIVES FOR PHARMACEUTICAL ANALYSIS IN INDIA

Sakshi Dixit, Prajwal Shelar*, Abhishek Patil and Shriniwas Patil

ABSTRACT

The importance of quality control(QC) testing by an analytical laboratory cannot be overstated, as it serves as one of the “checks and balance” between the pharmacy and consumer. We are all aware that a quality preparation is vital, and the QC laboratory should play an integral part in establishing the safety and accuracy of pharmacy preparations. As the compounding practice continues to evolve as well. Analytical challenges can cover a multitude of areas ranging from lack of an appropriate reference standard for comparative analysis to complication quantitative analysis by a complex sample matrix.[1] Estimation of the profile of organic impurities is the most challenging, most interesting task. The protocol for this begins with the detection of the impurities by chromatographic methods, mainly thin-layer chromatography (TLC) and/or HPLC. The next step is to attempt identification by retention matching with available potential impurities. If this fails, the structure of the impurities must be determined by on-line or off-line coupling of chromatographic and spectroscopic techniques.[2]

Keywords: (TLC) and/or HPLC.