Complete B.Pharm 1st Semester Pharmaceutical Analysis Notes Unit 1 to 5 explained with syllabus, titrations, limit tests, errors, and pharmaceutical applications for exam preparation.

Unit 1
1. Definition & Scope
- Pharmaceutical Analysis is defined as the branch of chemistry that deals with the process of determining the identity, quality, and quantity of pharmaceutical substances and formulations.
- Scope includes:
- Checking purity of drugs.
- Determining active pharmaceutical ingredients (APIs).
- Ensuring safety by testing for impurities.
- Standardizing raw materials.
2. Types of Analysis
- Qualitative Analysis – determines the presence of a substance (e.g., chloride test in sodium chloride).
- Quantitative Analysis – determines the amount of a substance (e.g., % purity of aspirin tablet).
3. Techniques of Analysis
- Chemical Methods –
- Titrimetric analysis (volumetric analysis).
- Gravimetric analysis.
- Instrumental Methods –
- UV-Visible spectroscopy, chromatography, potentiometry, etc.
4. Errors in Pharmaceutical Analysis
- Determinate (Systematic) Errors: reproducible errors like wrong standard solution preparation.
- Indeterminate (Random) Errors: occur by chance, e.g., reading fluctuation in burette.
- Personal Errors: due to observer, e.g., parallax error.
- Instrumental Errors: due to faulty instruments.
5. Minimization of Errors
- Calibration of instruments.
- Careful handling of reagents.
- Use of blank determinations.
- Repetition of experiments.
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Unit 2
1. Theories of Acids and Bases
- Arrhenius Theory: Acid produces H⁺, base produces OH⁻.
- Bronsted-Lowry Theory: Acid = proton donor, Base = proton acceptor.
- Lewis Theory: Acid = electron pair acceptor, Base = electron pair donor.
2. Neutralization Reactions
- Example: HCl + NaOH → NaCl + H₂O.
- Used to assay strong and weak acids/bases.
3. Buffers
- Solutions that resist pH changes.
- Example: Acetate buffer (CH₃COOH + CH₃COONa).
- Role in pharmacy: maintains stability of drugs, used in biological systems.
4. Indicators
- Substances that show endpoint by color change.
- Examples:
- Phenolphthalein (colorless → pink).
- Methyl orange (red → yellow).
5. Non-Aqueous Titrations
- Carried out in solvents other than water.
- Useful for weak acids/bases insoluble in water.
- Example: Assay of sodium benzoate using non-aqueous titration.
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Unit 3
1. Principle
- Based on oxidation and reduction reactions.
- Oxidizing agent → accepts electrons.
- Reducing agent → donates electrons.
2. Common Redox Reagents
- Potassium permanganate (KMnO₄) – strong oxidizing agent.
- Potassium dichromate (K₂Cr₂O₇) – oxidizing agent.
- Iodine (I₂) – used in iodometry and iodimetry.
- Cerium salts (Ce⁴⁺) – oxidizing agents.
3. Indicators in Redox Titrations
- Self-indicator: KMnO₄ acts as its own indicator.
- Starch solution: used in iodine titrations (blue complex).
- Diphenylamine: used with dichromate titrations.
4. Examples of Redox Titrations
- Permanganometry: Assay of ferrous sulfate using KMnO₄.
- Iodimetry/Iodometry: Determination of ascorbic acid, copper salts.
- Cerimetry: Assay of ferrous ammonium sulfate.
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Unit 4
1. Precipitation Titrations
- Based on the formation of insoluble precipitates.
- Common methods:
- Mohr’s Method: Uses chromate indicator. Example: Estimation of chloride using AgNO₃.
- Volhard’s Method: Back titration using thiocyanate.
- Fajans’ Method: Uses adsorption indicators like fluorescein.
2. Complexometric Titrations
Assay of calcium gluconate, magnesium salts, zinc oxide.
Based on complex formation between metal ions and ligands.
Common ligand: EDTA (Ethylenediaminetetraacetic acid).
Metal indicators: Eriochrome Black T (EBT), Murexide.
Applications:
Determination of hardness of water.
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Unit 5
1. Gravimetric Analysis
- Based on measurement of mass of a substance.
- Steps:
- Precipitation of analyte.
- Filtration.
- Washing.
- Drying/Ignition.
- Weighing.
- Example: Estimation of barium as barium sulfate.
2. Limit Tests
- Used to detect small quantities of impurities in pharmaceuticals.
- Limit Test for Chlorides: Precipitation with silver nitrate.
- Limit Test for Sulphates: Precipitation with barium chloride.
- Limit Test for Iron: Color comparison with thioglycolic acid.
- Limit Test for Arsenic: Reduction to arsine gas (Gutzeit test).
- Limit Test for Heavy Metals: Formation of colored sulfide precipitate.
3. Pharmaceutical Applications
- Ensures drugs are free from toxic impurities like arsenic, lead, and mercury.
- Maintains Indian Pharmacopoeia (IP) and USP standards.
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