Abstract
For pharmaceutical industry, HPLC is more than 40 years old. Even after instrumental advancements in HPLC problems still arise, troubleshooting still comes. HPLC is the main stay of analytical section nowadays in pharmaceutical industry whether it is API industry or formulation plant. Best approach for troubleshooting HPLC problems is going with systematic way. At the start of quantitative chromatographic analysis, the first parameter of paramount importance is baseline, especially for measuring the area of any given peak. Baseline usually suffers from these errors, namely, high baseline drift, periodic baseline fluctuation, and spikes. This article aims at suggesting some working methodologies which will resolve as well as avoid cases of such errors and failures.
Highlights
The practice of HPLC is more than 40 years old in pharmaceutical industry
Role of HPLC at present day in Pharmaceutical Industry HPLC is the main stay of analytical section nowadays in pharmaceutical industry whether it is API industry or formulation plant
Greater advantage with HPLC systems is automation associated with sampling sequence, sampling chamber temperature, column temperature, column choice flexibility considering its length or stationary phase material, and systems capacity to run for long time without any failure make are best tool for routine analysis
Summary
The practice of HPLC is more than 40 years old in pharmaceutical industry. HPLC has been improved by many advances in instrumentation and highly pure chemical components, problems still arise. Pressure fluctuations from pump Common causes of this pressure fluctuation associated with system hardware are: HPLC back pressure too low to maintain prime in system, worn or damaged pump piston seals, leaking or worn pump piston seal, and improper fitting of column or inline tubing Such problems can be resolved by proper training and technique to use system, but most importantly, it is maintenance related so it is advised to keep system in excellent condition. Perform regularly preventative maintenance and schedule inspection and cleaning of entire system to eliminate unproductive down time [54] Common causes of this pressure fluctuation associated with liquid component used in mobile phase are as follows: Flow rate inappropriate in the gradient program, mixing problem These spikes could be due to air bubbles in the detector cell, less likely with the new generation of inline vacuum degassing systems [50,58]
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