Pharmaceutical Analytical Techniques: How to Decide

Introduction and outcome:Analytical Techniques

Analytical techniques play a vital role in any pharmaceutical industry since they are essential for assessing the quality of pharmaceuticals such as purity, potency, and safety In this article, I will discuss the top 21 common Analytical techniques required for pharmaceutical development

Top 11 Common Analytical Techniques

HPLC (High-Performance Liquid Chromatography)

Principle: HPLC is a widely used technique for separating, identifying, and quantifying compounds in a mixture. It works on the solid stationary phase and liquid mobile phase and separation is achieved by partition, adsorption and ion exchange processes
Applications: HPLC is used for both qualitative and quantitative analysis such as impurity profiling, stability testing, and assay of pharmaceuticals.
Why Important: It is a versatile, reliable method that is routinely used in drug development, quality control, and regulatory testing

Check out this article for more details: How to understand HPLC?

GC (Gas Chromatography)

Principle: GC separates volatile compounds by passing them through a column coated with a stationary phase under the influence of a gas (called carrier gas) as the mobile phase.
Applications: GC is used for the qualitative and quantitative analysis of volatile substances like solvents, and residual solvents in pharmaceuticals.
Why Important: It is particularly useful for volatile, thermally stable compounds

Check out this article for more details: GC method development

GCMS

Principle: GCMS is the combination of GC with mass detector
Applications: GCMS is used for mass determination and structure elucidation of volatile pharmaceuticals
Why Important: It is highly sensitive and offers excellent specificity for analyzing complex mixtures, identifying unknown compounds, and characterizing impurities.

Check out this article for more details: GC-MS

LC MS or HPLC MS

Principle: LC MS is the combination of LC/HPLC with mass detector
Applications: LC MS is used for mass determination, impurities identification and structure elucidation of pharmaceuticals
Why Important: It is highly sensitive and offers excellent specificity for analyzing complex mixtures, identifying unknown compounds, characterising impurities and quantification of impurities at very low levels (e.g. quantification of nitrosamines)

Check out this article for more details: LC-MS

IR (Infrared Spectroscopy)

Principle: IR spectroscopy measures the absorption of infrared light by a sample, which causes molecular vibrations. The resulting spectrum provides information about functional groups and molecular structure.
Applications: It is widely used to confirm the identity of pharmaceuticals and functional group identification
Why Important: IR spectroscopy is non-destructive, simple to use, and provides rapid, qualitative analysis of pharmaceuticals

Check out this article for more details: FT IR Spectrophotometer and How to calibrate FTIR ?

UV-Vis Spectroscopy (Ultraviolet-Visible Spectroscopy)

Principle: UV-Vis spectroscopy measures the absorption of ultraviolet or visible light by a sample. The absorbance spectrum can be used to identify substances based .
Applications: It is commonly used for qualitative analysis like identification test
Why Important: UV-Vis is easy to use, fast, and cost-effective, making it a common tool for both routine and screening applications.

Check out this article for more details: UV Spectrometer Principle and How to calibrate UV?

Titration or Potentiometric titration

Principle: Titration involves adding a reagent of known concentration to a sample to determine the concentration of an analyte. Potentiometric titration uses a voltage response to determine the endpoint.
Applications: Titration is commonly used for the determination of pharmaceuticals, acidity, basicity and water content in pharmaceuticals
Why Important: It is a fundamental technique for quantitative analysis, offering accuracy and precision in a variety of pharmaceutical applications.

Check out this article for more details: Titration and How to Understand Normality, Molarity and Equivalent weight?

Karl Fischer Titrator

Principle: Titration involves adding a KF reagent of known concentration to a sample to measure water content.
Applications: It is used to measure water content of the pharmaceuticals
Why Important: Very helpful in managing quality at different levels during drug development

Check out this article for more details: KF titration for water determination and How to calibrate KF?)

DSC (Differential Scanning Calorimetry)

Principle: DSC measures the heat flow associated with physical transitions in a sample, such as melting, crystallization, or phase transitions.
Applications: It is used to assess the thermal properties of drug substances, including polymorphism, stability, and formulation characteristics.
Why Important: DSC provides valuable insights into the physical state of a drug and can be used to ensure consistent quality in drug formulations.

X-ray Diffraction (XRD)

Principle: X-ray diffraction analyzes the crystalline structure of substances by measuring the diffraction of X-rays through a sample.
Applications: XRD is used to study polymorphism, crystallinity, and solid-state properties of drugs.
Why Important: The technique is critical in determining the physical form of an API (active pharmaceutical ingredient), which can influence drug dissolution rates and bioavailability.

Nuclear Magnetic Resonance (NMR) Spectroscopy

Principle: NMR spectroscopy provides information about the molecular structure of compounds by measuring the interaction of atomic nuclei with magnetic fields.
Applications: NMR is used for the structural elucidation of new pharmaceuticals,
Why Important: NMR offers high specificity and can provide detailed structural insights, making it invaluable for research and development of new pharmaceuticals.

Conclusion

I hope this article has helped you understand common analytical techniques and their application. You may also want to check out other articles on my blog, such as How to Calibrate HPLC and UPLC

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Abbreviations

HPLC: High-performance liquid chromatography
UPLC: Ultrafast high-performance liquid chromatography

FAQs

What are the techniques of pharmaceutical analysis?

Analytical techniques like UV spectrophotometers, FTIR, HPLC, UPLC GC, GCMS, GCHS and titrations are used for pharmaceutical analysis

What are analytical methods in the pharmaceutical industry?

The titrimetric method, spectroscopic method and chromatographic method are used in pharmaceutical industries