UNIQUE SERIES AKTU Syllabus
BP610P SEC2

Analytical Method Development and Validation (Practical)

L-T-P0-0-2 Session2026-27 TypeLab / Practical
Appears in 1 semester

B.Pharm · Sem 6 (SEC – Elective 4)

Download PDF

List of Experiments / Activities

  1. Analytical Method Development and Validation (Practical) Elective Credit Hours Per Week (L-T-P) Max. Hours L T P
  2. 1-- --
  3. 30Maximum Marks SE ESE
  4. (Perform any 12 Experiments)
  5. 1Development of a UV-Visible spectrophotometric method for the assay of paracetamol API. Construction of calibration curve for a model API using UV-Visible spectrophotometry.
  6. 2Determination of solid dosage form by using dissolution method.
  7. 3Analytical method development and validation of Atenolol/metformin by using HPLC.
  8. 4Investigation of different columns for HPLC separation of a Multi-component Drug Mixture.
  9. 5Optimization of mobile Phase composition for HPLC analysis of a selected drug.
  10. 6Optimization of Flow rate and temperature in HPLC for paracetamol/ caffeine.
  11. 7Selection of wavelength for spectrophotometric analysis by HPLC of Marketed drugs.
  12. 9Determination of effect of pH on Retention time in RP-HPLC.
  13. 10Validation of HPLC method: Determination of LOD and LOQ for paracetamol by HPLC
  14. 11Preliminary Investigation of forced Degradation studies on Ibuprofen by HPLC.
  15. 12Method development for related substances of a drug substance using HPLC.
  16. 13Determination of residual solvent analysis for ethanol/acetone in API by using Gas Chromatography.
  17. 14Development of titrimetric method for the assay of marketed drugs (Ascorbic acid/sodium bicarbonate).
Course Objectives6 points
  • The objectives of this course are to:
  • Provide practical exposure to analytical method development using spectrophotometric, chromatographic, and titrimetric techniques for pharmaceutical analysis.
  • Introduce principles of optimization of analytical parameters such as wavelength, mobile phase composition, column selection, flow rate, temperature, and pH for reliable analysis.
  • Familiarize students with validation requirements of analytical methods as per regulatory guidelines, including assessment of sensitivity, linearity, and specificity.
  • Expose students to advanced chromatographic applications such as dissolution testing, impurity profiling, forced degradation studies, and residual solvent analysis.
  • Bridge analytical theory with industrial and regulatory practices relevant to quality control and quality assurance of pharmaceutical products.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Develop and optimize analytical methods using UV Visible spectrophotometry, HPLC, GC, and titrimetric techniques for pharmaceutical substances.
  2. CO2Construct calibration curves and perform quantitative estimation of APIs and formulations with appropriate analytical validation.
  3. CO3Select and optimize chromatographic conditions including column type, mobile phase composition, flow rate, temperature, and detection wavelength.
  4. CO4Apply analytical method validation parameters such as LOD, LOQ, and robustness to ensure reliability and regulatory compliance.
  5. CO5Conduct stability-indicating and impurity-related studies, including forced degradation, dissolution testing, and residual solvent analysis.
Recommended References (Preferably latest edition):6 books
  1. Ahuja S, Dong MW, editors. Handbook of pharmaceutical analysis by HPLC. Amsterdam: Elsevier; 2005.
  2. Moldoveanu SC. Method development in analytical HPLC. Amsterdam: Elsevier; 2014.
  3. Swartz ME, Krull I. Analytical method development and validation. Boca Raton (FL): CRC Press; 2018.
  4. Gorog S. Ultraviolet visible spectrophotometry in pharmaceutical analysis. Boca Raton (FL): CRC Press; 2018.
  5. Rehman K, Akash MSH. Essentials of pharmaceutical analysis. Singapore: Springer; 2020.
  6. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q2(R2): Validation of analytical procedures. Geneva: ICH; 2023. Course Title Course Type

Previous Year Papers

Loading…

🙏 Aapke juniors aur doston ko aapki zarurat hai!

Aapke paas is subject ka koi purana paper hai? Upload kijiye. Aapka ek paper kisi junior ka exam aasaan bana sakta hai.

Upload previous year paper

Official AKTU syllabus

This subject is on page 250, 251, 252 of the original AKTU PDF.

Official AKTU syllabus PDF ↗