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Related Concept Videos

High-Performance Liquid Chromatography: Introduction01:11

High-Performance Liquid Chromatography: Introduction

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High-performance liquid chromatography(HPLC), formerly referred to as High-pressure liquid chromatography, is a powerful technique used to separate, identify, and quantify components in complex mixtures. The term "high pressure" refers to using high pressure to push the liquid mobile phase through the tightly packed columns.
In HPLC, two phases play a critical role in the separation process:
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High-Performance Liquid Chromatography: Elution Process01:05

High-Performance Liquid Chromatography: Elution Process

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In High-Performance Liquid Chromatography (HPLC), the elution process is critical to the separation of analytes and the quality of chromatographic results. Elution describes how compounds move through the column and separate based on their interactions with the mobile and stationary phases. This process determines the resolution, peak shape, and retention times in the chromatogram, which are essential for identifying and quantifying components in complex mixtures. Understanding the elution...
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High-Performance Liquid Chromatography: Types of Detectors01:15

High-Performance Liquid Chromatography: Types of Detectors

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The role of the detectors in High-Performance Liquid Chromatography (HPLC) is to analyze the solutes as they exit from the chromatographic column. The detector recognizes the solute's property and generates corresponding electrical signals, which are converted into a readable graph of the detector's response versus elution time called a chromatogram at the computer. There are several types of HPLC detectors, each with its own advantages and limitations, depending on the analyte...
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High-Performance Liquid Chromatography: Instrumentation00:57

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High-performance liquid chromatography, or HPLC, is an analytical technique that separates liquid samples under high pressures. An HPLC instrument consists of glass bottles for storing solvents called mobile phase reservoirs. HPLC-grade solvents are used to maintain high purity, and the dissolved gases are removed using a degasser, such as a vacuum pumping system or sparging with helium. The solvents are then pumped into the analytical column using a screw-driven syringe or reciprocating pumps.
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A Novel, Stability-indicating Method for Analyzing Degradation Impurities in Hydrochlorothiazide and Irbesartan

Tusharkumar Shah1, Smriti Sharma2, Jayesh Dhalani1

  • 1Department of Chemistry, School of Science, RK University, Kasturbadham (Tramba), Rajkot, 360020, India.

Current Drug Research Reviews
|August 28, 2025
PubMed
Summary

A new HPLC method effectively identifies process-related impurities in irbesartan and hydrochlorothiazide combination tablets. This validated method ensures drug quality and supports routine impurity testing for these antihypertensive medications.

Keywords:
HPLCIrbesartanSIAMhydrochlorothiazideimpuritiesvalidation

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Area of Science:

  • Pharmaceutical Analysis
  • Analytical Chemistry
  • Drug Quality Control

Background:

  • Hydrochlorothiazide and irbesartan are common antihypertensive drugs often combined in a single pill.
  • Ensuring the quality of combination drug products is crucial for patient safety.

Purpose of the Study:

  • To develop and validate a standard screening method for process-related degradation products in irbesartan and hydrochlorothiazide tablets.
  • To establish a robust High-Performance Liquid Chromatography (HPLC) method for quantifying impurities in these drugs.

Main Methods:

  • Utilized a Kromasil L7 column with a ghost-busting column for separation.
  • Employed a mobile phase consisting of 0.1% orthophosphoric acid and acetonitrile.
  • Performed analysis using an Infinity 1290 system with UV detection at 220 nm and a column temperature of 30°C.

Main Results:

  • Achieved high correlation coefficients (r > 0.999) for eight impurities, indicating method linearity.
  • Demonstrated excellent recoveries (89.7-108.9%) for hydrochlorothiazide and irbesartan-related impurities.
  • Established low limits of quantification for critical impurities, ensuring sensitivity.

Conclusions:

  • The developed HPLC method is well-validated and suitable for routine analysis.
  • The method effectively screens for and quantifies process-related impurities in irbesartan and hydrochlorothiazide combination tablets.
  • This contributes to ensuring the quality and safety of antihypertensive drug products.