Volume : 10, Issue : 06, June – 2023
Title:
48.ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF LURASIDONE HCL IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
Authors :
Gattu Manisha*, Dr. M. Venkataramana , Dr Rangu Nirmala
Abstract :
A simple, accurate, precise and sensitive RP-HPLC assay method have been validated for the estimation of Lurasidone HCl in bulk and marketed pharmaceutical formulation.Lurasidone HCl is separated using Symmetry C18 ODS (4.6mm×150mm) 5µm particle size column and Methanol: Phosphate Buffer (0.05M-pH-4.8) (34:66) used as a mobile phase at a flow rate of 1.0ml/ minand effluent was detected at 315 nm. Here resolution was good, theoretical plate count and symmetry was appropriate. The retention time of Lurasidone HCl was found to be 2.248 minutes.Linearity was observed over concentration range of 30-60ng ml-1. The Limit of detection and limit of quantification was found to be 1.2ng ml-1 and 3.7ngml-1 respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98% to 102%. The above method was afforded excellent percentage recovery was found to be within the limits i.e. 98-102% The % RSD values were less than 2%.The validation parameters, tested in accordance with the requirements of ICH guidelines, prove the suitability of this method. The method was successfully applied for determination of drug in tablets, wherein no interference from tablet excipients was observed, indicating the specificity of the developed method.The proposed method was found to be simple, precise, accurate, rapid, economic and reproducible for the estimation of Lurasidone HCl in bulk and marketed pharmaceutical formulation.
Keywords: Lurasidone HCl, RP-HPLC, Accuracy, Precision, ICH Guidelines.
Cite This Article:
Please cite this article in press Gattu Manisha et al, Analytical Method Development And Validation For The Determination Of Lurasidone Hcl In Pharmaceutical Dosage Form By RP-HPLC., Indo Am. J. P. Sci, 2023; 10 (06).
Number of Downloads : 10
References:
1. Dr. Kealey and P.J Haines, Analytical Chemistry, 1stedition, Bios Publisher, (2002), PP 1-7.
2. A. Braith Wait and F.J. Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
3. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition, Academic press, (1997), PP 24-37.
4. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
5. Chromatography, (online). URL: http://en.wikipedia.org/wiki/Chromatography.
6. Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Ed. England, John Wiley & Sons Ltd, (2004), PP 7-8.
7. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
8. Introduction to Column. (Online),URL:http://amitpatel745.topcities.com/index_files/study/column care.pdf
9. Detectors used in HPLC (online )URL:http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC
10. Detectors (online) ,URL:http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html
11. Detectors (online) ,URL:http://www.dionex.com/enus/webdocs/64842-31644-02_PDA-100.pdf
12. Detectors (online),URL:http://www.ncbi.nlm.nih.gov/pubmed/8867705
13. Detectors (online),URL:http://www.chem.agilent.com/Library/applications/59643559.pdf
14. Detectors (online),URL:http://hplc.chem.shu.edu/new/hplcbook/detector
15. Draft ICH Guidelines on Validation of Analytical Procedures Definitions and terminology. Federal Register, vol 60. IFPMA, Switzerland, (1995), PP 1126.
16. Code Q2B, Validation of Analytical Procedures; Methodology. ICH Harmonized Tripartite Guidelines, Geneva, Switzerland, (1996), PP 1- 8.
17. Introduction to analytical method validation (online), available from: URL: http://www.standardbase.hu/tech/HPLC%20validation%20PE.pdf.
18. Data elements required for assay validation, (online) available from: URL: http://www.labcompliance.com/tutorial/methods/default.aspx.
19. Sánchez MLF. Chromatographic techniques, European RTN Project, GLADNET, retrieved on 05-09-2013.
20. Snyder LR, Kirkland JJ, Glach JL. Practical HPLC Method Development, John Wiley and Sons, New York, 1997; 158-192.
</div8