High Performance Liquid Chromatography (HPLC) use in Quality Control (QC) department of a Pharmaceutical Industry


HPLC use in Pharmaceutical Industry 




High Performance Liquid Chromatography (HPLC) has a plethora of applications in both laboratory (Quality Control (QC)), clinical sciences and pharmaceutical development. Some of its important applications in the QC department has been discussed in the discussion below.

HPLC use in Pharmaceutical Industry


Testing the content uniformity across batches of an oral dosage form 

Various oral dosage forms are being manufactured in pharmaceutical industries on regular basis. The concentration of active pharmaceutical ingredient (API) must be consistent in all of these products. It is of significant importance because it is one of the ways by which healthcare professionals ensure that patient is receiving the recommended dose of medicine. Thus, the consistent concentration of API in every oral dosage form is called “content uniformity” which is the most crucial step in controlling and maintaining the quality of these products. It can be analyzed by using HPLC. In this technique, sample is collected from different batches of an oral dosage form. Afterward, the QC analyst runs HPLC and detects the amount of API in each sample. In this way, the consistent concentration of API is being analyzed and verified among all batches. 

Ensuring the safe use of medicines by detecting impurities

The presence of adulterants in dosage forms gives rise to a life-threatening situation for a patient. It hinders the efficacy of the API which in turn causes Adverse Drug Reactions (ADRs) and Adverse Drug Events (ADEs). Consequently, detection of impurities through HPLC is a fundamental step towards QC of each product. As HPLC chemically separates the constituents of the sample, thus it becomes easy for the QC analyst to identify the presence of any such impurity.  Analyzing safety of the drugs

All pharmaceutical agents are liable to deteriorate with the passage of time. The rate of drug deterioration depends on various factors which mainly include, (i) exposure of drug to sunlight or oxygen, (ii) humidity level in the atmosphere, and many more such determinants. All these factors contribute in changing the quantity, potency, efficacy and stability of the API. Thus, drug safety is effectively and efficiently analyzed by using HPLC. This instrument is efficient in analyzing the stability of the drug at different stages of its lifecycle under various circumstances. Moreover, it is beneficial in developing the shelf life and storage guidelines of the final product.

Constructing the dissolution profile of a drug

According to United States Pharmacopoeia (USP), the dissolution time reflects the bioavailability of the drug and its uniformity assessment with particular reference to the manufacturing scale and site. Thus, HPLC is of prime importance in determining the amount of API at different time intervals. For this reason, it is specially designed, by using monolithic column instead of particle based column, for doing rapid and efficient separation of the constituents of the sample.  

Carrying out of Metabonomic study

“Drug undergoes various biochemical changes upon exposing the human system. This process is called metabonomics”. Such investigations are meant to discover new metabolites of the drug along with their therapeutic and toxic profiles during in-vitro and in-vivo studies. For this reason, HPLC is being employed for reliable, accurate and reproducible analysis of the drugs.

Conducting Bioequivalence and Pharmacokinetic Analysis

In order to determine the pharmacokinetic and bioequivalent profile of a therapeutic agent, it is essential to quantify drug in the biological sample. Owing to the sensitivity and selectivity of HPLC at low detection level, this technique gives reliable and accurate data which can be used for the statistical evaluation of pharmacokinetics and bioequivalence. Moreover, it analyzes low molecular weight in both pre-clinical and clinical studies. 

Screening of synthetic compounds

HPLC is an efficient tool in carrying out the high-quantity screening of the synthetic drugs. Due to the relative high sensitivity, low need of sample purity, no requirement of personnel expertise and the use of cost effective solvents, HPLC not only simplifies the analytical procedures, but it also gives automation to the procedure by employing software for exact mass measurement. 

Analyzing the Fixed Dose Combination (FDC) Drugs

In case of FDC products, solubility of each therapeutic agent is difficult to maintain. As a result, HPLC accurately analyzes such products in short span of time.

Developing the method and its validation

As per Food and Drug Administration (FDA), validation is a method to develop a documented proof which ensures and specifies the quality of the drugs. It is a time consuming and complex procedure because it encompasses the use of pH, mobile phase, temperature, gradient profiles and column chemistries, to get a reliable and robust separation for every activity. Thus by using HPLC, methods can be optimized in just one or two hours, analysis times become as short as one minute, along with the significant reduction of the time required for method development and validation.