Pharmaceutical_Analysis_Unit_hhhhhI.pptx

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1. Pharmaceutical Analysis – Unit I Definition, Techniques, Concentration Methods, and Standardization

2. WELCOME TO THE UNIVERSITY

3. Pharmaceutical Analysis: Definition and Scope Definition: Deals with identification, quantification, and purification of drugs. Scope: - Quality control & assurance - Regulatory compliance - Impurity detection - R&D support - Pharmacokinetic studies

4. Techniques of Analysis 1. Qualitative Analysis: Identification of compounds (e.g., TLC, color tests) 2. Quantitative Analysis: - Gravimetric (mass-based) - Volumetric ( titration / vol ) Acid base,non -Aq./ complexometric / ppt titration) - Instrumental (UV, HPLC, etc.)

5. Methods of Expressing Concentration solution , conc , std sol 1. Molarity (M): mol /L 2. Molality (m): mol /kg solvent 3. Normality (N): equivalents/L 4. % w/w, w/v, v/v 5. ppm (parts per million) mass of solute/mass of solution*10 6 6. Mole fraction /molar proportion.

6. NaOH / OXALIC ACID Sodium atomic mass :23 Cl: 35.5 O: 16 H: 1 Mwt:H2C2O4?

7. Primary and Secondary Standards Primary Standards: - High purity, stable, known composition - Examples: Oxalic acid, Na2CO3 Secondary Standards: - Standardized using primary standards - Examples: NaOH, HCl, KMnO4

8. Standard Solution: Oxalic Acid Preparation: Dissolve weighed oxalic acid in water. Standardization: Titrate with NaOH (Indicator: Phenolphthalein) Reaction: H2C2O4 + 2NaOH → Na2C2O4 + 2H2O

9. Standard Solution: Sodium Hydroxide Preparation: Dissolve NaOH pellets in water. Standardization: Use standard oxalic acid. Indicator: Phenolphthalein

10. Standard Solution: Hydrochloric Acid Preparation: Dilute concentrated HCl . Standardization: Use sodium carbonate. Reaction: Na2CO3 + 2HCl → 2NaCl + CO2 + H2O Indicator: Methyl orange

11. Standard Solution: Sodium Thiosulphate Preparation: Dissolve in water with Na2CO3. Standardization: Use iodine or potassium dichromate. Reaction: I2 + 2Na2S2O3 → 2NaI + Na2S4O6 Indicator: Starch

12. Standard Solution: Sulphuric Acid Preparation: Dilute concentrated H2SO4. Standardization: Use sodium carbonate. Indicator: Methyl orange

13. Standard Solution: Potassium Permanganate Preparation: Dissolve & filter KMnO4 in warm water. Standardization: Use oxalic acid (warm). Reaction: 2MnO4⁻ + 5C2O4²⁻ + 16H⁺ → 2Mn²⁺ + 10CO2 + 8H2O Self-indicating

14. Standard Solution: Ceric Ammonium Sulphate Preparation: Dissolve in dilute H2SO4. Standardization: Use ferrous ammonium sulfate (FAS). Indicator: Ferroin or diphenylamine sulfonate