Pharmaceutical and Drug Analysis

Study Notes

Drug analysis involves testing complex matrices like blood, drug materials, and tissues.
Recent applications include pharmaceutical industries, clinical laboratories, and forensic science.
Quality Control (QC) is crucial in pharmaceutical industries, checking raw materials and products.
QC ensures pharmaceutical product safety and consistent quality.

Focuses on raw materials and pharmaceutical formulations.
Identifies, detects, and analyses drug components.
Stability studies assess properties, purity, and active pharmaceutical ingredients (API) content.
Validated analytical schemes from pharmacopeias ensure medication safety and effectiveness.

Qualitative analysis identifies substance composition.
- Examples include precipitate formation, limit tests, color change, and freezing/boiling point tests.
Quantitative analysis determines substance amounts.
- Examples include measuring reaction products and calculating drug concentration/recovery percentages.

Analysis based on the quantitative reaction between analyte and reagent (titrant).
Direct titrations involve a rapid reaction between analyte and standard. Examples include acid-base titrations and ibuprofen assays.
Residual titrations use an excess titrant, then titrate it with a second titrant. An example is aspirin assay.
Complexometric titrations rely on forming a stable complex between analyte and reagent. Example: metal ion titrations using EDTA.
Redox titrations use oxidation-reduction reactions. One example is vitamin C assay.
Advantages include simplicity, low cost, and ease of use without sophisticated instruments
Disadvantages include destructiveness, limited accuracy, and dependence on environmental factors like temperature and moisture.

Separates mixture components.
Thin-layer chromatography (TLC) uses a thin layer of adsorbent (e.g., silica gel).
Column chromatography uses a stationary bed (e.g., liquid or gas).
- Gas chromatography (GC) uses a gas mobile phase.
- Liquid chromatography (LC) uses a liquid mobile phase.
- Advantages: Separates many complex mixtures quickly, uses a variety of solvents, and can be used to analyze high volumes of samples.
- Disadvantages: Time-consuming and potentially expensive.

Uses fixed wavelengths (400-700 nm) to determine concentrations of colored solutions.
Analysis helps determine concentrations in colored samples.

Beta-lactam antimicrobials used for bacterial infections.
Five generations based on gram-positive/negative bacteria and resistance.
Mechanistically, they inhibit bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), which prevents cross-linking of peptidoglycan.

Involves consuming the substance (e.g., penicillin) in a multi-step process to reach desired results.
It's used when the reaction rate is slow with direct titration.