THE USE OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN PHARMACEUTICAL ANALYSIS
Abstract
THE USE OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN PHARMA-CEUTICAL ANALYSIS (Abstract): The aim of the study was to provide a review and strategy for the development and validation of a modern analytical method with nearly unparalleled accuracy in the pharmaceutical analysis. High performance liquid chromatography is an analytical method used to separate, identify and quantify components dissolved in a liquid solvent with a high analytical resolution. Because of its versatility, HPLC is used in a variety of industrial and scientific applications, such as pharmaceutical, environmental, forensics, and chemicals. Characteristics that should be considered during validation of analytical methods include specificity, linearity, range, accuracy, precision, detection limit, quantification limit, robustness.
References
1. Cecchi T. Ion-Pair Chromatography and Related Techniques. Chapter 3. Boca Raton: CRC Press Taylor & Francis Group LLC, 2010.
2. Apostu M, Bibire N, Ţântaru G. Chimie Analitică Vol. III. Iaşi: Ed. Performantica, 2009.
3. ***The European Pharmacopoeia, 9th ed., Strasbourg: Council of Europe, 2016.
4. ***The United States Pharmacopoeia 28. United States Pharmacopoeial Convention. MD; 2004.
5. Fachi MM, Leonart LP, Cerqueira LB, Degaut Pontes FL, Leandro de Campos M, Pontarolo R. A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood. J Chromatogr B 2017; 1055-1056: 61-71.
6. Bakshi A, Korey A, Fowler W, Banga A. Development and validation of an HPLC-UV method for analysis of methylphenidate hydrochloride and loxapine succinate in an activated carbon disposal sys-tem. J Pharm Anal 2018; 8(6): 349-356.
7. Hashem H, El-Sayeda H. Quality by design approach for development and validation of a RP-HPLC method for simultaneous determination of co-administered levetiracetam and pyridoxine HCl in pre-pared tablets. Microchem J 2018; 143: 55-63.
8. Bibire N, Ţântaru G, Apostu M, Agoroaei L, Vieriu M, Panainte AD, Vlase A. A New Bioanalytical Method for the Determination of Alprazolam in Human Plasma. Rev Chim (Bucharest) 2013; 64(6): 587-592.
9. Creţeanu A, Ţântaru G, Vieriu M, Panainte AD, Ochiuz L. Development and Validation of A Method For Quantitative Determination Of Amiodarone Hydrochloride In Blood Serum By HPLC-MS-MS. Rev Med Chir Soc Med Nat Iasi 2017; 121(2): 427-432.
10. Martínez-Ortega A, Herrera A, Salmerón-García A, Cabeza J, Cuadros-Rodríguez L, Navas N. Vali-dated reverse phase HPLC diode array method for the quantification of intact bevacizumab, infliximab and trastuzumab for long-term stability study. Int J Biol Macromol 2018; 116: 993-1003.
11. Bibire N, Vieriu M, Țântaru G, Apostu M, Agoroaei L, Panainte AD, Znagovan A, Vlase A. A New and Sensitive LC-MS/MS Method for the Determination of Clopidogrel in Human Plasma. Rev Chim (Bucharest) 2014; 65(7): 807-810.
12. Mastanamma SK, Chandini SK, Reehana SK, Saidulu P. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Sofosbuvir and Ledipasvir in bulk and their combined dosage form. FJPS 2018; 4(2): 116-123.
13. Moussa BA, Hashem H, Mahrouse MA, Mahmoud ST. A validated RP-HPLC method for the deter-mination of rosuvastatin in presence of sacubitril/valsartan in rat plasma: Application to in vivo eval-uation of OATP-mediated drug interaction potential between rosuvastatin and sacubitril/valsartan. Microchem J 2018; 143: 31-38.
14. Panainte AD, Vieriu M, Țântaru G, Apostu M, Bibire N, Avasilcăi L, Morariu ID. Rp-Hplc Analysis Method of Bisoprolol Fumarate in A New Tablet Formulation. Rev Med Chir Soc Med Nat Iasi 2018; 122(3): 634-639.
15. Ramaswamy A, Smith A, Dhas AG. Development and validation of analytical method for quantitation of Emtricitabine, Tenofovir, Efavirenz based on HPLC. Arab J Chem 2018; 11(2): 275-281.
16. Kongkiatpaiboon S, Duangdee N, Chewchinda S, Poachanukoon O, Amnuaypattanapon K. Develop-ment and validation of stability indicating HPLC method for determination of adrenaline tartrate. JKSUS 2019, 31(1): 48-51.
17. Panainte AD, Vieriu M, Ţântaru G, Apostu M, Bibire N. Fast RP-HPLC method for the determination of bisoprolol. Rev Med Chir Soc Med Nat Iasi 2016; 120(3): 720-726.
18. Gedawy A, Al-Salamia H, Dass C. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide. JFDA 2019; 27(1): 315-322.
19. Dahshan HE, Helal M, Mostafa S, Elgawish MS. Development and validation of an HPLC-UV method for simultaneous determination of sildenafil and tramadol in biological fluids: Application to drug-drug interaction study. J Pharm Biomed Anal 2019, 168: 201-208.
20. Sahu PK, Ramisetti NR, Cecchi T, Swain S, Patro CS, Panda J. An overview of experimental designs in HPLC method development and validation. J Pharm Biomed Anal 2018; 147: 590-611.
21. ***Agilent Chem Station for LC 3D System. Understanding Your Spectra Module. Agilent Technol-ogies, 2003.
22. Yuwono M, Indryanto G. Validation of chromatographic method of analysis. in: Brittain HG (editor). Profiles of drug substances, excipients, and related methodology. Vol. 32. Orlando: Academic Press, 2006, 243-262.
23. ICH Topic Q2B: Validation of Analytical Procedures (CPMP/ICH/281/95). The European Agency for the Evaluation of Medicinal Products, 1995.
24. Roman L, Bojiță M, Săndulescu R. Validarea metodelor de analiză și control. București: Ed. Medicală, 1998.
25. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. 2nd Edition. New Jersey: John Wiley & Sons Inc., 2012.
26. Oprean R, Rozet E, Dewé W, Boulanger B, Hubert Ph. Ghid de validare a procedurilor analitice cantitative. Cluj-Napoca: Ed. Medicală Universitară “Iuliu Hațieganu”, 2007.
27. Jaba E. Statistica. Ed. a III-a. Bucureşti: Ed. Economică, 1998.
28. Carr GP, Wahlich JC. A practical approach to method validation in pharmaceutical analysis. J Pharm Biomed Anal 1990; 8: 613-618.
29. Somenath M, Brukh R. Sample preparation techniques in analytical chemistry. New Jersey: John Wiley & Sons Inc., 2003.
30. ***Reviewer guidance. Validation of Chromatographic Methods. Center for Drug Evaluation and Research (CDER), FDA 1994.
31. ***Guideline for Submitting Samples and Analytical Data for Methods Validation, FDA, 1987.
32. Detlef W. Application Note. Development and validation of an HPLC method to analyze IBP and impurities according to the European Pharmacopoeia. Agilent Technologies Inc., 2010.
33. ***Center for Drug Evaluation and Research (C'DER) C enter for Biologies Evaluation and Research (CBER). Analytical Procedures and Methods Validation for Drugs and Biologies. Guidance for In-dustry. US Department of Health and Human Services Food and Drug Administration, 2015.
34. ***World Health Organization. Guidelines on Validation - Appendix 4. Analytical Method Validation, 2016.
35. Otto M. Chemometrics-Statistic and Computer Application in Analytical Chemistry, 3rd edition Wein-heim: Wiley−VCH, 2017.
36. Del Castillo E. Process Optimization a Statistical Approach. New York: Springer, 2007.
37. Ferreira SLC, Caires AO, Borges TS, Lima AMDS, Silva LOB, dos Santos WNL. Robustness evalua-tion in analytical methods optimized using experimental designs. Microchem J 2017; 131: 163-169.
2. Apostu M, Bibire N, Ţântaru G. Chimie Analitică Vol. III. Iaşi: Ed. Performantica, 2009.
3. ***The European Pharmacopoeia, 9th ed., Strasbourg: Council of Europe, 2016.
4. ***The United States Pharmacopoeia 28. United States Pharmacopoeial Convention. MD; 2004.
5. Fachi MM, Leonart LP, Cerqueira LB, Degaut Pontes FL, Leandro de Campos M, Pontarolo R. A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood. J Chromatogr B 2017; 1055-1056: 61-71.
6. Bakshi A, Korey A, Fowler W, Banga A. Development and validation of an HPLC-UV method for analysis of methylphenidate hydrochloride and loxapine succinate in an activated carbon disposal sys-tem. J Pharm Anal 2018; 8(6): 349-356.
7. Hashem H, El-Sayeda H. Quality by design approach for development and validation of a RP-HPLC method for simultaneous determination of co-administered levetiracetam and pyridoxine HCl in pre-pared tablets. Microchem J 2018; 143: 55-63.
8. Bibire N, Ţântaru G, Apostu M, Agoroaei L, Vieriu M, Panainte AD, Vlase A. A New Bioanalytical Method for the Determination of Alprazolam in Human Plasma. Rev Chim (Bucharest) 2013; 64(6): 587-592.
9. Creţeanu A, Ţântaru G, Vieriu M, Panainte AD, Ochiuz L. Development and Validation of A Method For Quantitative Determination Of Amiodarone Hydrochloride In Blood Serum By HPLC-MS-MS. Rev Med Chir Soc Med Nat Iasi 2017; 121(2): 427-432.
10. Martínez-Ortega A, Herrera A, Salmerón-García A, Cabeza J, Cuadros-Rodríguez L, Navas N. Vali-dated reverse phase HPLC diode array method for the quantification of intact bevacizumab, infliximab and trastuzumab for long-term stability study. Int J Biol Macromol 2018; 116: 993-1003.
11. Bibire N, Vieriu M, Țântaru G, Apostu M, Agoroaei L, Panainte AD, Znagovan A, Vlase A. A New and Sensitive LC-MS/MS Method for the Determination of Clopidogrel in Human Plasma. Rev Chim (Bucharest) 2014; 65(7): 807-810.
12. Mastanamma SK, Chandini SK, Reehana SK, Saidulu P. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Sofosbuvir and Ledipasvir in bulk and their combined dosage form. FJPS 2018; 4(2): 116-123.
13. Moussa BA, Hashem H, Mahrouse MA, Mahmoud ST. A validated RP-HPLC method for the deter-mination of rosuvastatin in presence of sacubitril/valsartan in rat plasma: Application to in vivo eval-uation of OATP-mediated drug interaction potential between rosuvastatin and sacubitril/valsartan. Microchem J 2018; 143: 31-38.
14. Panainte AD, Vieriu M, Țântaru G, Apostu M, Bibire N, Avasilcăi L, Morariu ID. Rp-Hplc Analysis Method of Bisoprolol Fumarate in A New Tablet Formulation. Rev Med Chir Soc Med Nat Iasi 2018; 122(3): 634-639.
15. Ramaswamy A, Smith A, Dhas AG. Development and validation of analytical method for quantitation of Emtricitabine, Tenofovir, Efavirenz based on HPLC. Arab J Chem 2018; 11(2): 275-281.
16. Kongkiatpaiboon S, Duangdee N, Chewchinda S, Poachanukoon O, Amnuaypattanapon K. Develop-ment and validation of stability indicating HPLC method for determination of adrenaline tartrate. JKSUS 2019, 31(1): 48-51.
17. Panainte AD, Vieriu M, Ţântaru G, Apostu M, Bibire N. Fast RP-HPLC method for the determination of bisoprolol. Rev Med Chir Soc Med Nat Iasi 2016; 120(3): 720-726.
18. Gedawy A, Al-Salamia H, Dass C. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide. JFDA 2019; 27(1): 315-322.
19. Dahshan HE, Helal M, Mostafa S, Elgawish MS. Development and validation of an HPLC-UV method for simultaneous determination of sildenafil and tramadol in biological fluids: Application to drug-drug interaction study. J Pharm Biomed Anal 2019, 168: 201-208.
20. Sahu PK, Ramisetti NR, Cecchi T, Swain S, Patro CS, Panda J. An overview of experimental designs in HPLC method development and validation. J Pharm Biomed Anal 2018; 147: 590-611.
21. ***Agilent Chem Station for LC 3D System. Understanding Your Spectra Module. Agilent Technol-ogies, 2003.
22. Yuwono M, Indryanto G. Validation of chromatographic method of analysis. in: Brittain HG (editor). Profiles of drug substances, excipients, and related methodology. Vol. 32. Orlando: Academic Press, 2006, 243-262.
23. ICH Topic Q2B: Validation of Analytical Procedures (CPMP/ICH/281/95). The European Agency for the Evaluation of Medicinal Products, 1995.
24. Roman L, Bojiță M, Săndulescu R. Validarea metodelor de analiză și control. București: Ed. Medicală, 1998.
25. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. 2nd Edition. New Jersey: John Wiley & Sons Inc., 2012.
26. Oprean R, Rozet E, Dewé W, Boulanger B, Hubert Ph. Ghid de validare a procedurilor analitice cantitative. Cluj-Napoca: Ed. Medicală Universitară “Iuliu Hațieganu”, 2007.
27. Jaba E. Statistica. Ed. a III-a. Bucureşti: Ed. Economică, 1998.
28. Carr GP, Wahlich JC. A practical approach to method validation in pharmaceutical analysis. J Pharm Biomed Anal 1990; 8: 613-618.
29. Somenath M, Brukh R. Sample preparation techniques in analytical chemistry. New Jersey: John Wiley & Sons Inc., 2003.
30. ***Reviewer guidance. Validation of Chromatographic Methods. Center for Drug Evaluation and Research (CDER), FDA 1994.
31. ***Guideline for Submitting Samples and Analytical Data for Methods Validation, FDA, 1987.
32. Detlef W. Application Note. Development and validation of an HPLC method to analyze IBP and impurities according to the European Pharmacopoeia. Agilent Technologies Inc., 2010.
33. ***Center for Drug Evaluation and Research (C'DER) C enter for Biologies Evaluation and Research (CBER). Analytical Procedures and Methods Validation for Drugs and Biologies. Guidance for In-dustry. US Department of Health and Human Services Food and Drug Administration, 2015.
34. ***World Health Organization. Guidelines on Validation - Appendix 4. Analytical Method Validation, 2016.
35. Otto M. Chemometrics-Statistic and Computer Application in Analytical Chemistry, 3rd edition Wein-heim: Wiley−VCH, 2017.
36. Del Castillo E. Process Optimization a Statistical Approach. New York: Springer, 2007.
37. Ferreira SLC, Caires AO, Borges TS, Lima AMDS, Silva LOB, dos Santos WNL. Robustness evalua-tion in analytical methods optimized using experimental designs. Microchem J 2017; 131: 163-169.
Additional Files
Published
2019-03-29
Issue
Section
PHARMACY
License
COPYRIGHT
Once an article is accepted for publication, MSJ requests a transfer of copyrights for published articles.
COPYRIGHT TRANSFER FORM FOR
REVISTA MEDICO-CHIRURGICALĂ A SOCIETĂȚII DE MEDICI ȘI NATURALIȘTI DIN IAȘI /
THE MEDICAL-SURGICAL JOURNAL OF THE SOCIETY OF PHYSICIANS AND NATURALISTS FROM IASI
We, the undersigned authors of the manuscript entitled
_____________________________________________________________________________________
_____________________________________________________________________________________
warrant that this manuscript, which is submitted for publication in the REVISTA MEDICO-CHIRURGICALĂ, has not been published and it is not under consideration for publication in another journal.
- we give the consent for publication in the REVISTA MEDICO-CHIRURGICALĂ, in printed and electronic format and we transfer unconditioned and complete the copyright of this manuscript to the REVISTA MEDICO-CHIRURGICALĂ, in the event of its acceptance.
- the manuscript does not break the intellectual property rights of any other person.
- we have read the submitted version of the manuscript and we are fully responsible for the content.
Names and signatures of authors / copyright owners (the following sequence is the authorship of the article):
- ______________________________/_________________________
- ______________________________/_________________________
- ______________________________/_________________________
N.B. All the authors must sign this form
