Volume : 13, Issue : 01, January – 2026

Title:

STABILITY INDICATING METHOD DEVELOPMENT & VALIDATION OF LORCASERIN HYDROCHLORIDE BY RP-HPLC METHOD

Authors :

Pragati Ranjan Satpathy*, K Saravanan and Nilima Shukla

Abstract :

The current investigation aimed to develop and progressively validate a novel, simple, responsive, and stable RP-HPLC method for the Quantitative Determination of Lorcaserin Hydrochloride in active pharmaceutical ingredients and marketed pharmaceutical dosage forms. A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Lorcaserin Hydrochloride. The chromatographic strategy utilised a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm, with isocratic elution using a mobile phase consisting of Phosphate Buffer (0.02 M) and Acetonitrile (pH 2.80) in a 60:40 v/v ratio. A flow rate of 1.0 ml/min and a detector wavelength of 225nm, utilising the UV detector, were given in the instrumental settings. Validation of the proposed method was carried out according to the International Conference on Harmonisation (ICH) guidelines. LOD and LOQ for the active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, which means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, and ruggedness were determined as part of method validation, and the results were found to be within the acceptable range. The proposed method is to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drugs.
Key Words:Lorcaserin Hydrochloride, RP-HPLC, Method Development, Validation, Accuracy

Cite This Article:

Please cite this article in press Pragati Ranjan Satpathy et al., Stability Indicating Method Development & Validation Of Lorcaserin Hydrochloride By Rp-Hplc Method, Indo Am. J. P. Sci, 2026; 13(01).

REFERENCES:

1. Olander, D.P., Instrumental Methods of Analysis, SixthEdition (Willard, Hobart H.; Merritt, Lynne L.; Dean, John A.; Settle, Frank A., Jr.). Journal of Chemical Education, 1984. 61(8): p. A222.
2. Lipka, E. and C. Vaccher, Quantitative analysis of drugs in biological matrices by HPLC hyphenated to fluorescence detection. Bioanalysis, 2015. 7(6): p. 743-762.
3. Choudhury, H., et al., Development and validation of RP-HPLC method: scope of application in the determination of oil solubility of paclitaxel. J ChromatogrSci, 2014. 52(1): p. 68-74.
4. Md Sabir, A., M. Moloy, and P. S Bhasin, HPLC METHOD DEVELOPMENT AND VALIDATION: A REVIEW. Vol. 4. 2015. 39-46.
5. Malherbe, C.J., D. de Beer, and E. Joubert, Development of on-line high performance liquid chromatography (HPLC)-biochemical detection methods as tools in the identification of bioactives. Int J Mol Sci, 2012. 13(3): p. 3101-33.
6. International Journal of Trend in Scientific Research and Development (IJTSRD) ISSN: 2456-6470 @ IJTSRD |
7. Hopmann, E., W. Arlt, and M. Minceva, Solvent system selection in counter-current chromatography using conductor-like screening model for real solvents. J Chromatogr A, 2011. 1218(2): p. 242-50.
8. Xiang, Y., Y. Liu, and M.L. Lee, Ultrahigh pressure liquid chromatography using elevated temperature. J Chromatogr A, 2006. 1104(1-2): p. 198-202.
9. Martin, M. and G. Guiochon, Effects of high pressure in liquid chromatography. J Chromatogr A, 2005. 1090(1-2): p. 16-38.
10. Seger, C., S. Sturm, and H. Stuppner, Mass spectrometry and NMR spectroscopy: modern high-end detectors for high resolution separation techniques–state of the art in natural product HPLC-MS, HPLC-NMR, and CE-MS hyphenations. Nat Prod Rep, 2013. 30(7): p. 970-87.
11. Malviya, R., et al., High performance liquid chromatography: A short review. Vol. 2. 2010. 22-26.
12. Jerz, G., et al., Separation of amaranthine-type betacyanins by ion-pair high-speed countercurrent chromatography. J Chromatogr A, 2014. 1344: p. 42-50.
13. Pfaunmiller, E.L., et al., Affinity monolith chromatography: a review of principles and recent analytical applications. Anal BioanalChem, 2013. 405(7): p. 2133-45.
14. Leon-Gonzalez, M.E., et al., Two-dimensional liquid chromatography for direct chiral separations: a review. BiomedChromatogr, 2014. 28(1): p. 59-83.
15. Kraiczek, K.G., et al., Highly flexible UV-vis radiation sources and novel detection schemes for spectrophotometric HPLC detection. Anal Chem, 2014. 86(2): p. 1146-52.
16. Ping, B.T.Y., H.A. Aziz, and Z. Idris, Comparison of Peak-area Ratios and Percentage Peak Area Derived from HPLC-evaporative Light Scattering and Refractive Index Detectors for Palm Oil and its Fractions. J Oleo Sci, 2018. 67(3): p. 265-272.
17. Kupina, S. and M. Roman, Determination of total carbohydrates in wine and wine-like beverages by HPLC with a refractive index detector: First Action 2013.12. J AOAC Int, 2014. 97(2): p. 498-505.
18. Pragst, F., M. Herzler, and B.T. Erxleben, Systematic toxicological analysis by high- performance liquid chromatography with diode array detection (HPLC-DAD). Clin Chem Lab Med, 2004. 42(11): p. 1325-40.
19. Raut, P.P. and S.Y. Charde, Simultaneous estimation of levodopa and carbidopa by RP-HPLC using a fluorescence detector: its application to a pharmaceutical dosage
20. Zhang, M., et al., Monitoring gradient profile on-line in micro- and nano-high performance liquid chromatography using conductivity detection. J Chromatogr A, 2016. 1460: p. 68-73.
21. Michalski, R., Application of ion chromatography in clinical studies and pharmaceutical industry. Mini Rev Med Chem, 2014. 14(10): p. 862-72.
22. Harikrishnan, Review on Stability Indicating HPLC Method Development, International Journal of Innovative Pharmaceutical Re- search. 2012; 3(3): 229-237.
23. Breaux J, Jones K, Boulas P., Understanding and implementing efficient analytical methods development and validation. Pharm Technol Anal Chem Test. 2003; 5:6-13.
24. K. Huynh-Ba, Development of Stability indicating methods, Handbook of Stability Testing in Pharmaceutical Development, Springer. 2009; 153.
25. International Conference on Harmonization, Draft Guidance on specifications, Test procedures and acceptance criteria for new drug substances and products, Chemical Sub- stances. Fed. Regist. 2000; 3(5): 83041-63.
26. Putheti RR, Okigbo RN, Patil SC, Advanapu MS, Leburu R. Method development and validations, Characterization of critical elements in the development of pharma- ceuticals. Int J Health Res. 2008; 1:11-20.
27. Wood R. How to Validate Analytical Methods. Trends Analyt Chem. 2005; 54: 149-58.
28. M.W. Dong, Modern HPLC for practicing scientists, John Wiley & Sons, New Jersey, (2006).
29. Validation of Analytical Procedures: Text and Methodology, International Conferences on Harmonization, Draft Revised (2005), Q2 (R1).
30. Chetan Kedari*, HemlataBhavar and Sagar Magar, a review on estimation of Lorcaserin hydrochloride in bulk and tablet dosage form, World Journal of Pharmaceutical Research, Volume 8, Issue 1, 677-682.
31. Hemlata S. Bhawar*, Chetan C. Kedari, Sagar D. Magar , Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Lorcaserin Hydrochloride in Bulk and Tablet Dosage Form, Journal of Drug Delivery and Therapeutics, 9(4):245- 250