Volume : 12, Issue : 04, April – 2025
Title:
REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR ANTIBACTERIAL DRUG
Authors :
Shraddha V. Iipte, Suraj D. Sagrule
Abstract :
The rising incidence of bacterial infections and the growing challenge of antimicrobial resistance have underscored the need for accurate, reliable, and rapid analytical techniques to ensure the quality and therapeutic efficacy of antibacterial agents. High-performance liquid chromatography (HPLC), particularly reverse-phase HPLC (RP-HPLC), remains a crucial analytical tool for pharmaceutical analysis due to its precision, sensitivity, and reproducibility. This study aims to develop and validate a simple, specific, and robust RP-HPLC method for the quantification of a selected antibacterial agent in both its pure form and formulated products.
Method development involved systematic optimization of various chromatographic parameters, including the selection of the stationary phase, mobile phase composition, flow rate, and detection wavelength. A C18 reversed-phase column was employed, and an isocratic elution using a mixture of acetonitrile and water (with appropriate pH adjustment) provided well-resolved, sharp peaks with acceptable retention times. Optimal flow rate and detection wavelength were selected to enhance sensitivity and minimize peak tailing, ensuring accurate and reliable quantification.
Cite This Article:
Please cite this article in press Shraddha V. Iipte et al., Review On Analytical Method Development And Validation Of Rp-Hplc For Antibacterial Drug, Indo Am. J. P. Sci, 2025; 12(04).
Number of Downloads : 10
References:
1. Bakshi, M., & Singh, S. (2002). Development of validated stability-indicating assay methods. Journal of Pharmaceutical and Biomedical Analysis, 28(6), 1011–1040.
2. Blessy, M., Patel, R. D., Prajapati, P. N., & Agrawal, Y. K. (2014). Development of forced degradation and stability indicating studies of drugs—A review. Journal of Pharmaceutical Analysis, 4(3), 159–165.
3. ICH. (2005). Validation of Analytical Procedures: Text and Methodology Q2 (R1). International Conference on Harmonization.
4. Snyder, L. R., Kirkland, J. J., & Dolan, J. W. (2011). Introduction to Modern Liquid Chromatography (3rd ed.). Wiley.
5. Kazakevich, Y., & Lobrutto, R. (2007). HPLC for Pharmaceutical Scientists. Wiley-Interscience.
6. Meyer, V. R. (2010). Practical High-Performance Liquid Chromatography (5th ed.). Wiley.
7. Swartz, M. E., & Krull, I. S. (2012). Analytical Method Development and Validation. CRC Press.
8. Sethi, P. D. (2001). HPLC: High Performance Liquid Chromatography Quantitative Analysis of Pharmaceutical Formulations. CBS Publishers.
9. FDA. (2015). Analytical Procedures and Methods Validation for Drugs and Biologics. U.S. Food and Drug Administration.
10. Niazi, S. K. (2007). Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products (2nd ed.). CRC Press.
11. Shrivastava, A., & Gupta, V. B. (2011). Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chronicles of Young Scientists, 2(1), 21–25.
12. Dong, M. W. (2006). Modern HPLC for Practicing Scientists. Wiley-Interscience.
13. Kumar, S., & Rathore, A. S. (2016). Analytical method validation and transfer: A comprehensive guide. BioPharm International, 29(3), 36–42.
14. Singh, S., & Bakshi, M. (2000). Guidance on conduct of stress tests to determine inherent stability of drugs. Pharmaceutical Technology Online, 24(2), 1–14.
15. Rieger, M. M. (1993). High-Performance Liquid Chromatography in Cosmetics and Pharmaceutical Industries. Marcel Dekker.
16. Paolella, A. (2012). Application of HPLC to pharmaceutical analysis. Current Pharmaceutical Analysis, 8(2), 167–175.
17. Skoog, D. A., Holler, F. J., & Crouch, S. R. (2013). Principles of Instrumental Analysis (7th ed.). Cengage Learning.
18. Huber, L. (2007). Validation and Qualification in Analytical Laboratories. Informa Healthcare.
19. Gupta, V. K., Jain, R., & Verma, R. (2006). High-performance liquid chromatographic methods for the determination of pharmaceutical compounds. Analytical Chemistry: An Indian Journal, 5(7), 354–361.
20. Kumar, V., & Parmar, D. (2013). RP-HPLC method development and validation for pharmaceutical analysis: A review. International Research Journal of Pharmacy, 4(4), 57–63.
21. Sharma, B. K. (2005). Instrumental Methods of Chemical Analysis. Goel Publishing House.
22. Ermer, J., & Miller, J. H. M. (2005). Method Validation in Pharmaceutical Analysis: A Guide to Best Practice. Wiley-VCH.
23. United States Pharmacopeia (USP) 42-National Formulary (NF) 37. (2019). United States Pharmacopeial Convention.
24. European Medicines Agency. (2014). Guideline on Bioanalytical Method Validation.
25. Patil, P., & Pethe, P. (2013). HPLC method development and validation—An overview. International Research Journal of Pharmacy, 4(4), 57–62.
26. Dighe, S. B., et al. (2017). HPLC method development and validation for pharmaceutical analysis—A review. World Journal of Pharmacy and Pharmaceutical Sciences, 6(7), 305–321.
27. Chatwal, G. R., & Anand, S. K. (2010). Instrumental Methods of Chemical Analysis (5th ed.). Himalaya Publishing House.
28. Jain, D., & Jain, S. (2010). Method development and validation using HPLC technique—A review. Journal of Pharmaceutical and Biomedical Sciences, 7(7), 1–5.
29. Reddy, M. B., et al. (2011). Analytical method development and validation: A concise review. International Journal of Pharmaceutical Sciences and Research, 2(11), 3057–3070.
30. Bansal, S., & DeStefano, A. (2007). Key elements of bioanalytical method validation for small molecules. The AAPS Journal, 9(1), E109–E114.