Volume : 12, Issue : 02, February – 2025
Title:
RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ALECTINIB FOR THE ESTIMATION OF API AND PHARMACEUTICAL FORMULATION
Authors :
Mr. Vishal N. Chavan*, Snehal K. Pharate, Saurabh B. More, Dr. Kamble H.V, Mr. Sugriv R. Ghodake, Dr. Santosh Waghmare
Abstract :
A simple and efficient isocratic reversed-phase HPLC method for the quantitative estimation of Alectinib in bulk drug and pharmaceutical formulations has been developed and validated as per ICH guidelines. The method demonstrated excellent linearity, accuracy, precision, specificity, and system suitability. Validation studies confirmed no interference from excipients, with the recovery studies showing high accuracy. The method exhibited low %RSD, suggesting high precision and sensitivity, and was proven to be robust under varying conditions such as flow rate and mobile phase composition. The proposed method is rapid, cost-effective, and environmentally friendly due to lower solvent consumption. Statistical analysis indicated no significant difference in the results, affirming the reliability of the method. This HPLC method can be used for routine quality control analysis of Alectinib in both bulk manufacturing and marketed dosage forms.
Keywords: Alectinib, RP-HPLC, Method Development, Method Validation, Accuracy, Precision, Specificity, ICH Guidelines.
Cite This Article:
Please cite this article in press Vishal N. Chavan et al., RP-HPLC Method Development And Validation Of Alectinib For The Estimation Of Api And Pharmaceutical Formulation., Indo Am. J. P. Sci, 2025; 12 (02).
Number of Downloads : 10
References:
1. Ahuja S. and Dong M.W., “Handbook of Pharmaceutical Analysis by HPLC Separation Science and Technology”, 1st Edition, Academic press , (6): 336-337
2. Mazzo D.J., “International Analytical Testing”, Interpharm Press, Inc., USA, 1999: 11-18
3. ICH, International Conference on Harmonization: Method Development and Validation of New Drug substance and Product, Q2A(R1), 2003: Geneva
4. Acharya M.M, “Pharmaceutical Stability Testing and Studies, An overview”, The Eastern Pharmacist, 1999: 31-36
5. Charde M. S., Kumar J., Welankiwar A. S. and Chakole R.D., Development of forced degradation studies of drugs, International Journal of Advance in Pharmaceutics,2013,2(3):35-39
6. Chatwal G.R. and Anand S.K., Instrumental Method of Chemical Analysis, 5th Edition, Himalaya Publishing House, Mumbai: 2005: p.25
7. www.formsci.co.,http://www.forumsci.co.il/HPLC/program.html&usg21April20
8. 16,11:40
9. www.pharmaaricales.net/exclusive/technical/basic-principles-of-hptlc.html
10. 21April 2016,12:55
11. ICH, Validation of Analytical Procedures: Text and Methodology, Q2(R1), Current Step 4 Version, Parent Guideline, 1994 : 630.
12. B.k Sharma, Instrumental methods of chemical analysis, Introduction to analytical chemistry, Goel publication , Meerut. 23, 2007.
13. Lindholm.J, Development and Validation of HPLC Method for Analytical and Preparative purpose. Acta Universitatis Upsaliensis, 2004, 13-14.
14. Rashmin, An introduction to analytical Method Development for Pharmaceutical formulations. Indoglobal Journal of Pharmaceutical Sciences, 2(2), 2012, 191-
15. 196.
16. Malvia R, Bansal V , Pal O.P and Sharma P.K. A Review of High Performance Liquid Chromatography. Journal of Global Pharma technology. 2010.
17. Douglas A Skoog, F. James Holler, Timothy A. Niemen, Principles of Instrumental Analysis 725-760.
18. Dr.S. Ravi Shankar, Text book of Pharmaceutical analysis, Fourth edition, 13.1- 13.2
19. David G.Watson. Pharmaceutical Analysis, A text book for Pharmacy students and Pharmaceutical Chemists. Harcourt Publishers Limited; 2, 221-232.
20. Remingtonn’s The Sciences and Practise of Pharmacy, 20, 2000.
21. Connors Ka. A Textbook of Pharmaceutical Analysis, Wiley intersciences Inc; Delhi, 3, 373 -421, 1994.
22. Gurdeep R.Chatwal , Sham K .Anand, Instrumental Methods of Chemical Analysis , 2007, 2.566 -2.638
23. Nasal.A, Siluk.D, and Kaliszan.R. Chromatographic Retention Parameters in Medicinal Chemistry and Pharmacology, Pubmed, 10(5), 2003, 381-426.
24. Ashok Kumar, Lalith Kishore, navpreet Kaur, Anroop Nair. Method Development and Validation for Pharmaceutical Analysis. International Pharmaceutica Sciencia, 2(3), 2012.
25. Kaushal.C, Srivatsava.B, A Process of Method Development: A Chromatographic Approach. J Chem Pharm Res, Vol.2, Issue 2, 519-545, (2010)
26. Green JM. A Practicle guide to analytical method validation, Anal Chem 1996, 305A-309A
27. ICH, Validation of analytical procedures: Text and Methodology. International Conference on Harmonization, IFPMA , Geneva, 1996.
28. IUPAC. Compendium of Chemical Terminology, 2nd edn. (The Gold Book). PAC69, 1137 Glossary of terms used in computational drug design (IUPAC Recommendations 1997.
29. K. D. Tripathi, Essentials of Medical Pharmacology, 6th Edition, Jaypee brother’s medical publishers (P) LTD, 254-255.
30. Indian Pharmacopoeia, Indian Pharmacopoeial Commission, Controller of Publication, Government of India, Ministry of health and Family Welfare, Ghaziabad, India, 2, 2010, 1657-1658.
31. British Pharmacopoeia, The British Pharmacopoeial Commission, the stationary office, UK, London, 2, 2011, 1408-1409.
32. Zhao Z, Li P, Han Y, Yan H. Honeycomb resin-based spin-column solid-phase extraction for efficient determination of alectinib and its metabolite in human urine. Journal of Chromatography A. 2023 Feb 8;1690:463787.
33. Gulikers JL, Veelen AJ, Sinkiewicz EM, Beer YM, Slikkerveer M, Stolk LM, Tjan‐Heijnen VC, Hendriks LE, Croes S, Geel RM. Development and validation of an HPLC–MS/MS method to simultaneously quantify brigatinib, lorlatinib, pralsetinib, and selpercatinib in human K2‐EDTA plasma. Biomedical Chromatography. 2023 Jun;37(6):e5628.
34. Kolasani DD, Desai M, Patil P, Channabasavaiah JP. Evaluation of pH Dependent Solubility and Examination of Variation in Pharmacokinetic Properties of Alectinib: A Quantitative Study by Implementing Integrated Quality by Design Approach for RP-HPLC Method Development and Optimization. Indian Journal of Pharmaceutical Education and Research. 2022 Oct 1;56(4):1219-25.
35. Wilkinson S, Gupta A, Scheuer N, Mackay E, Arora P, Thorlund K, Wasiak R, Ray J, Ramagopalan S, Subbiah V. Assessment of alectinib vs ceritinib in ALK- positive non–small cell lung cancer in phase 2 trials and in real-world data. JAMA Network Open. 2021 Oct 1;4(10):e2126306-.
36. Heinig K, Herzog D, Ferrari L, Fraier D, Miya K, Morcos PN. LC–MS/MS determination of alectinib and its major human metabolite M4 in human urine: prevention of nonspecific binding. Bioanalysis. 2017 Mar;9(5):459-68.
37. Liu M, Zhang L, Huang Q, Li N, Zheng B, Cai H. Cost-effectiveness analysis of ceritinib and alectinib versus crizotinib in the treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. Cancer Management and Research. 2019 Oct 25:9195-202.
38. Maithani M, Singh R. Development and validation of a stability-indicating HPLC method for the simultaneous determination of salbutamol sulphate and theophylline in pharmaceutical dosage forms. J Anal Bioanal Techniques. 2011;1(116):11.
39. Singh R, Maithani M, Saraf SK, Saraf S, Gupta RC. Simultaneous estimation of ciprofloxacin hydrochloride, ofloxacin, tinidazole and ornidazole by reverse phase–high performance liquid chromatography. Eurasian J Anal Chem. 2009 Jul 1;4(2):161-7.
40. Maithani M, Dwivedi D, Hatwal D, Bansal P. Development and validation of a RP-HPLC method for determination of Erdafitinib in marketed formulations. Journal of Biomedical and Pharmaceutical Research. 2020: 9(3): 1-6.
41. ICH (1996) The European Agency for the Evaluation of Medicinal Products.ICH Topic Q2B Note for Guideli. ne on Validation of Analytical Procedures: Methodology. GPMP/ICH/281/95.
42. ICH Harmonised Tripartite Guideline (2005) Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, 1-13.
43. ICH Guidance on Analytical Method Validation, International Convention on Quality for the Pharmaceutical Industry: Toronto, Canada, 2002.
44. Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SH, Pérol M, Dziadziuszko R, Rosell R, Zeaiter A. Alectinib versus crizotinib in untreated ALK-positive non–small-cell lung cancer. New England Journal of Medicine. 2017 Aug 31;377(9):829-38.
45. Larkins E, Blumenthal GM, Chen H, He K, Agarwal R, Gieser G, Stephens O, Zahalka E, Ringgold K, Helms W, Shord S. FDA approval: alectinib for the treatment of metastatic, ALK-positive non–small cell lung cancer following crizotinib. Clinical Cancer Research. 2016 Nov 1;22(21):5171-6.
46. Paik J, Dhillon S. Alectinib: a review in advanced, ALK-positive NSCLC. Drugs. 2018 Aug;78:1247-57.
47. Keage K. Alectinib: a review of its use in advanced ALK-rearranged non-small cell lung cancer. Drugs. 2015 Jan;75:75-82.
48. Rao TN, Srinivas Y. Method development and validation of alectinib drug by RP- HPLC in bulk and pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis. 2018 Dec 1;8(4).
49. Veelen A, Geel R, Schoufs R, Beer Y, Stolk LM, Hendriks LE, Croes S. Development and validation of an HPLC–MS/MS method to simultaneously quantify alectinib, crizotinib, erlotinib, gefitinib and osimertinib in human plasma samples, using one assay run. Biomedical Chromatography. 2021 Dec;35(12):e5224