HPTLC method development and validation: Strategy to minimize methodological failures

Journal of Food and Drug Analysis

Volumn 20, Issue 4, 2012, Pages

  Rashmin, Patel ^a   Mrunali, Patel ^b   Nitin, Dubey ^c   Nidhi, Dubey ^d   Bharat, Patel ^e  

^a AR Patel and GH Patel Institute of Pharmacy   (India)

^b Indukaka Ipcowala College of Pharmacy   (India)

^c IPS Academy   (India)

^d DEVI AHILYA UNIVERSITY   (India)

^e CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY   (India)

Author keywords

HPTLC; Method development; Method validation

Indexed keywords

ALIPHATIC HYDROCARBON; ALKALOID DERIVATIVE; AMINOPHENOL DERIVATIVE; AROMATIC HYDROCARBON; BARBITURIC ACID DERIVATIVE; FLAVONOID; NUCLEIC ACID BASE; NUCLEOTIDE DERIVATIVE; PHENOL DERIVATIVE; PHTHALIC ACID; POLYCYCLIC AROMATIC HYDROCARBON; PURINE DERIVATIVE; PYRIMIDINE DERIVATIVE; STEROID; SULFONIC ACID DERIVATIVE; TERPENE DERIVATIVE; TETRACYCLINE DERIVATIVE;

ANALYTIC METHOD; CHIRALITY; DERIVATIZATION; DRUG DETERMINATION; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY; LIMIT OF DETECTION; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; PHASE TRANSITION; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; REVIEW; SENSITIVITY AND SPECIFICITY; SEPARATION TECHNIQUE; VALIDATION PROCESS;

EID: 84875153451     PISSN: 10219498     EISSN: None     Source Type: Journal    
DOI: 10.6227/jfda.2012200408     Document Type: Review

References (34)

1. Patel, R. B., Patel, M. R. and Patel, B. G. 2011. Experimental aspects and implementation of HPTLC. In "High performance thin layer chromatography (HPTLC)". pp. 41-54. Srivastava, M. M. ed. Springer Berlin Heidelberg, New York, USA.
2. Sherma, J. 2008. Modern thin layer chromatography. J. AOAC Int. 91: 1142-1144.
3. Patel, M. R., Patel, R. B. and Parikh, J. R. et al. 2010. HPTLC method for estimation of tazarotene in topical gel formulations and in vitro study. Anal. Methods 2: 275-281.
4. Patel, R. B., Patel, A. B. and Patel, M. R. et al. 2009. Estimation of alprazolam and sertraline in pure powder and tablet formulations by high-performance liquid chromatography and high-performance thin-layer chromatography methods. Anal. Lett. 42: 1588-1602.
5. Patel, R. B., Shankar, M. B. and Patel, M. R. et al. 2008. Simultaneous estimation of acetylsalicylic acid and Clopidogrel bisulfate in pure powder and tablet formulations by high-performance column liquid chromatography and high-performance thin-layer chromatography. J. AOAC Int. 91: 750-755.
6. Patel, R. B., Patel, M. R. and Bhatt, K. K. et al. 2010. HPTLC method development and validation: Quantification of paliperidone in formulations and in vitro release study. Anal. Methods. 2: 525-531.
7. Patel, R. B., Patel, M. R. and Shankar, M. B. et al. 2009. Simultaneous determination of alprazolam and fluoxetine hydrochloride in tablet formulations by high-performance column liquid chromatography and high-performance thin-layer chromatography. J. AOAC Int. 92: 1082-1088.
8. Patel, M. R., Patel, R. B. and Parikh, J. R. et al. 2011. HPTLC method for estimation of isotretinoin in topical formulations, equilibrium solubility screening and in vitro permeation study. J. Liq. Chrom. Rel. Tech. 34: 1783-1799.
9. Patel, R. B., Patel, M. R. and Bhatt, K. K. et al. 2011. Development and validation of HPTLC method for estimation of carbamazepine in formulations and its in vitro release study. Chrom. Res. Int. 2011: 684369. doi:10.4061/2011/ 684369.
10. Patel, R. B., Patel, M. R. and Bhatt, K. K. et al. 2010. Development and validation of on HPTLC method for determination of olanzapine in Formulations. J. AOAC Int. 93: 811-819.
11. Renger, B. 2001. Planar chromatographic procedures in pharmaceutical analysis. J. AOAC Int. 84: 1217.
12. Krzek, J. and Sherma, J. 2010. New planar chromatography - densitometry methods for determination of drug substances and formulations. J. AOAC Int. 93: 751-753.
13. Shabir, G. A., Lough, W. J. and Arain, S. A. et al. 2007. Evaluation and application of best practice in analytical method validation. J. Liq. Chrom. Rel. Tech. 30: 311-333. (Pubitemid 46034161)
14. Ferenczi-Fodor, K., Vegh, Z. and Nagy-Turak, A. et al. 2001. Validation and quality assurance of planar chromatographic procedures in pharmaceutical analysis. J. AOAC Int. 84: 1265-1276. (Pubitemid 33610561)
15. ICH Harmonised Tripartite Guideline. 2005. Validation of analytical procedures: text and methodology, Q2 (R1) Geneva, http://www.ich.org. (Accessed on 01.04.2012)
16. Camag planar chromatography catalog; CAMAG Scientific Inc.: Wilmington, NC, 2010/11, http://www.camag.com. (Accessed on 01.04.2012)
17. Camag parameters for planar chromatography - useful hints, CAMAG, Muttenz, Switzerland, http://www.camag.com. (Accessed on 01.04.2012)
18. Koll, K., Reich, E. and Blatter, A. et al. 2003. Validation of standardized high-performance thin-layer chromatographic methods for quality control and stability testing of herbals. J. AOAC Int. 86: 909-915.
19. Sherma, J. 2010. Review of HPTLC in drug analysis: 1996-2009. J. AOAC Int. 93: 754-764.
20. Jaenchen, D. E. and Reich, E. 2000. Planar chromatography: instrumentation. In "Encyclopedia of separation science", pp. 839-847. Iwan, W., Colin, P. and Michael, C. ed. Academic Press, New York, USA.
21. rd ed. pp. 538-550. Swarbrick, J. ed. Informa Healthcare, London, UK.
22. nd ed. Marcel Dekker, Inc., New York, USA.
23. Sethi, P. D. 1996. High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations. CBS Publishers, New Delhi, India.
24. Renger, B. 1993. Quantitative planar chromatography as a tool in pharmaceutical analysis. J. AOAC Int. 76: 7-13.
25. Renger, B. 1998. Contemporary thin layer chromatography in pharmaceutical quality control. J. AOAC Int. 81: 333-339. (Pubitemid 128439724)
26. Reich, E., Schibli, A. and Debatt, A. 2008. Validation of high-performance thin-layer chromatographic methods for the identification of botanicals in a cGMP environment. J. AOAC Int. 91: 13-20. (Pubitemid 351315739)
27. Swartz, M. 2009. Chromatography: method validation. In "Handbook of Methods and Instrumentation in Separation Science", pp. 614-620. Wilson, I. D. and Poole, C, ed. Academic Press, CA, USA.
28. Ferenczi-Fodor, K., Renger, B. and Végh, Z. 2010. The frustrated reviewer - recurrent failures in manuscripts describing validation of quantitative TLC/HPTLC procedures for analysis of pharmaceuticals. J. Planar. Chrom. 23: 173-179.
29. Yuwono, M. and Indrayanto, G. 2005. Validation of chromatographic methods of analysis. In "Profiles of drug substances, excipients and related methodology", pp. 243-259. Brittain, H. ed. Academic Press, USA.
30. Huber, L. 2003. Validation of analytical methods and processes. In "Pharmaceutical process validation third edition-revised and expanded". Nash, R. A. and Wachter, A. H. ed. Marcel Dekker, Inc. New York, USA.
31. Huber, L. 2011. Validation of analytical methods: review and strategy, http://www.labcompliance.com. (Accessed on 03.02.2012)
32. Ermer, J. and Miller, J. 2005. Method validation in pharmaceutical analysis. A guide to best practice. WILEYVCH Verlag GmbH & Co. KGaA, Weinheim, Germany.
33. rd ed. pp. 92-113. Swarbrick, J. ed. Informa Healthcare, London, UK.
34. Indrayanto, G. 2011. Analytical aspects of thin layer chromatography. In "High performance thin layer chromatography (HPTLC)". pp. 179-201. Srivastava, M. M. ed. Springer-Verlag Berlin Heidelberg, New York, USA.