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Importance of HPLC in Pharmaceuticals & Medicines

High performance liquid chromatography (HPLC) is used in the pharmaceutical and medicine manufacturing industry to test products, and the ingredients used to make them. This testing is often performed by a pharmaceutical company's quality control (QC) laboratory. Chemists employed by these manufacturers will run samples of raw materials or finished goods through HPLC machines and then analyze the results.

  1. Significance

    • HPLC holds significance in the field of pharmaceuticals and medicine, in part, because these industries fall under the stringent regulations established by the U.S. Food and Drug Administration (FDA). If a company fails to test products using such methods as HPLC, FDA can issue 483 Warning Letters or even shut down a company's production via court order. High performance liquid chromatography is especially significant for the pharmaceutical and medicine industries because it allows for both qualitative and quantitative analysis.

    Benefits

    • A benefit for a pharmaceutical company in using high performance liquid chromatography is the quality assurance this test provides. Another is that HPLC methods are relatively standard in the industry. This means new hires with experience in the pharmaceutical field require minimal training before they begin to perform testing in the laboratories. Additionally, the standard performance of HPLC testing enables contract manufacturers to transfer methods to their facilities from the company contracting production.

    Function

    • HPLC is used to analyze raw materials and finished products to assure that pre-established quality levels are being met. HPLC begins as a high-pressure pump generates and meters a specified flow rate from a reservoir holding solvent. An injector introduces the sample into the continuously flowing mobile phase stream that carries the sample into the HPLC column. A detector is used to measure the separated compound bands as they elute from the HPLC column. The mobile phase exits the detector and can be either collected or sent to waste.

    Considerations

    • When a pharmaceutical company uses HPLC, method validation must be performed to ensure accuracy in material detection. This often entails spiking a sample with a known quantity of an active ingredient and comparing the results to that of a blank sample. When methods from the various pharmacopoeias (USP, etc.) are used, it is not necessary to evaluate their suitability.

    Potential

    • With the use of HPLC, a company has the potential to discover faulty products which do not meet specification. This allows the manufacturer to avoid an expensive and reputation-damaging recall by not releasing the product in the first place. Given that an entire lot of tablets or caplets cannot be tested in a reasonable amount of time, representative samples are collected, using ANSI (American National Standards Institute) standards, and tested with HPLC.

    Standard Operating Procedures

    • An important component of pharmaceutical companies is a robust Standard Operating Procedure program which serves to specify how functions are to be performed. Chemists who use HPLC machines need to follow their company's procedures when analyzing material. Employees in the industry receive SOP training throughout the course of the year, and specific procedures must be established and followed for HPLC analysis.

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