Method development and validation are continuous processes that progress in parallel with the evolution of drug products. Changes encountered during drug development may require modifications to existing analytical methods. These modifications to the methods, in turn, may require additional validation. The advent of new techniques and improved instrumentation in the field of analysis may give way to more sensitive, precise, and accurate methods if the existing methods are erratic or unreliable; time-consuming, or too expensive. Thus, continuous new analytical method development and validation activities are essential for the growing drug development programs.
Cite this article:
Akash D. Rajmane, Komal P. Shinde. A Review of HPLC Method Development and Validation as per ICH Guidelines. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):143-1. doi: 10.52711/2231-5675.2023.00024
Akash D. Rajmane, Komal P. Shinde. A Review of HPLC Method Development and Validation as per ICH Guidelines. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):143-1. doi: 10.52711/2231-5675.2023.00024 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-2-13
1. ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology. ICH Harmonised Tripartite Guidelines, 1994.
2. Kumaraswamy. Gandla, D. Sudheer Kumar, Joru Praveen, Emmadi Suman. RP-HPLC Method Development and Validation for Simultaneous Estimation of Lignocaine Hydrochloride and Clotrimazole Hydrochloride in Ear Drops. Asian J. Pharm. Ana. 2017; 7(3): 163-168.
3. Jyoti Sonawane, Sonali Rathod, Sonali Suryawanshi, Durgesh Kale, Chaudhari Amit. Development and Validation of RP-HPLC Method for Estimation of Lacosamide in Bulk and Its Pharmaceutical Formulation. Asian Journal of Pharmaceutical Analysis. 2022; 12(1): 23-28.
4. B. Bhavya, P. Nagaraju, V. Mounika, G. Indira Priyadarshini. Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Albendazole and Ivermectin in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2017; 7(1): 6-14.
5. Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian J. Pharm. Ana. 2016; 6(4): 201-206.
6. Kirthi A, Shanmugam R, Mohana Lakshmi S, Ashok Kumar CK, Padmini K, Shanti Prathyusha M, Shilpa V. Analytical Method Development and Validation of a Stability-indicating RP-HPLC Method for the Analysis of Danazol in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2016; 6(4): 227-234.
7. Remi. S. L, Joyamma Varkey, R. K. Maheshwari, A. Jayakumaran Nair. A Novel Eco-friendly, Cost-effective mobile phase for HPLC- Simultaneous estimation and Validation of Paracetamol and Diclofenac sodium in Bulk and Pharmaceutical Formulation by RP-HPLC using Hydrotropic Solution as Mobile phase. Asian J. Pharm. Res. 2020; 10(3): 163-170.
8. Hamid Khan. Analytical Method Development in Pharmaceutical Research: Steps involved in HPLC Method Development. Asian J. Pharm. Res. 2017; 7(3): 203-207.
9. Ayesha Anees, Asra Ali Bahazeq, MD. Muzaffar-Ur-Rehman, Syed Akbar, Juveria Mehveen`. Development and Validation of Memantine Hydrochloride by RP-HPLC Method. Asian J. Pharm. Res. 2019; 9(2): 69-74.
10. Sufiyan Ahmad, Ansari Sajjad, Md. Rageeb Md. Usman, Mohammed Imran, Rashid Akhtar. Development and Validation of RP- HPLC Method for Simultaneous Estimation of Metformin and Miglitol in Bulk and Dosage Form. Asian J. Pharm. Res. 2017; 7(3): 139-147.
11. Botsa Parvatamma, Tentu Nageswara Rao, T.B. Patrudu, Karri Apparao. A New High-Performance Liquid Chromatographic Method for Identification and Quantification of Fosinopril Sodium and its related Impurities in Bulk Drug Product. Asian J. Pharm. Res. 2017; 7(3): 165-170.
12. Samer Housheh. Development of Rapid, Simple, and Stability-Indicating Method for Determination of Azithromycin Using RP-HPLC. Asian J. Pharm. Res. 2017; 7(2): 55-59.
13. Prabhu Venkatesh Moodbidri, Varadaraji Dhayanithi, Ganesh Belavadi Manjunathashastry, Hari Narayan Pati, Pardhasaradhi Vasireddy. A New Simultaneous Determination of Rosuvastatin Calcium and its Lactone Impurity by Reverse Phase HPLC method. Asian J. Pharm. Res. 2015; 5(4): 175-182.
14. Nurhabibah, A.K. Nugroho, Ronny Martien, Endang Lukitaningsih. Solubility Studies and Validation of Lovastatin using High-Performance Liquid Chromatography Method. Research Journal of Pharmacy and Technology. 2021; 14(12): 6285-8.
15. Sridevi. S, Vijayakumar. R, C. N. Nalini. Method Development and Validation for the Simultaneous Estimation of Ascorbic acid, Phenylephrine HCl, Paracetamol, and Levocetirizine HCl using RP-HPLC. Research J. Pharm. and Tech., 2020; 13(4): 1911-1916.
16. Merugu Manasa, Vijey Aanandhi M. Stability Indicating Method Development and Validation of Semaglutide by RP-HPLC in Pharmaceutical substance and Pharmaceutical Product. Research J. Pharm. and Tech., 2021; 14(3): 1385-1389.
17. Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati. New stability indicating RP-HPLC method for determination of Palestine in bulk and pharmaceutical formulation. Research J. Pharm. and Tech., 2020; 13(6): 2849-2853.
18. Baokar Shrikrishna, Ranpise Nisharani. Analytical Method Development and Validation for Simultaneous Estimation of Montelukast and Ebastine by HPLC. Research J. Pharm. and Tech. 2015; 8(1): 01-05.
19. Vishakha Shingote, S. D. Mankar, S. B. Dighe. A Review Article on Analytical Methods Development and Validation. Research Journal of Science and Technology. 2022; 14(1): 77-3.
20. Nachiket S. Dighe, Ganesh S. Shinde, Jyoti. J. Vikhe. Simultaneous Estimation, Validation, and Force Degradation Study of Metformin Hydrochloride and Empagliflozin by RP-HPLC Method. Research J. Science and Tech. 2019; 11(2): 135-147.
21. Ramya. B, Vinutha Kommineni, Sridevi Pingali, M. Bhagavan Raju. Novel Spectrophotometric Method for Determination of Non-Nucleoside Reverse Transcriptase Inhibitor in Bulk and Pharmaceutical Dosage Form. Research J. Science and Tech. 2018; 10(1): 19-27.
22. RS Jadhav, PN Kendre, MH Kolhe, S N Lateef, SM Shelke, RK Godge. RP- HPLC Method for Simultaneous Estimation of Ofloxacin and Ornidazole from Bulk and Tablets. Research J. Science and Tech. 2009; 1(1): 43-46.
23. P. B. Jadhav, S. G. Bhokare, M. N. Madibone. Development and Validation of an RP-HPLC Method for Pamabrom in Bulk and Pharmaceutical Dosage Form. Research J. Science and Tech. 2019; 11(3): 179-182.
24. Chaskar Swati G., Avhad Pawan S. Stability Indicating RP-HPLC Method Development and Validation of Esmolol in Bulk and Injection. Research J. Science and Tech. 2020; 12(2): 136-142.
25. Rupali Tambe, Someshwar Mankar, Santosh Dighe. Analytical Method Development and Validation of Paliperidone: A Review. Research J. Science and Tech. 2020; 12(1): 23-35.
26. Yogita Dighe, Dr. R. B. Laware, Dr. S. B. Dighe. Analytical Method Development and Validation of Linezolidine – A Review. Research J. Science and Tech. 2020; 12(1): 13-22.