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Vol. 11 No. 3 (2023): 2023 Volume -11 - Issue 3

Copyright (c) 2023 Badugu Sandhya

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Analytical Method Development and Validation for Simultaneous Estimation of Loratadine and Pseudoephedrine in Bulk and Tablet Dosage Form by RP HPLC Method

https://doi.org/10.61096/ijamscr.v11.iss3.2023.257-265
Badugu Sandhya
Department of Pharmaceutical Quality Assurance, Pydah College of PharmacyPatavala,Andhra University, Kakinada, Andhra Pradesh, India

Corresponding Author(s) : Badugu Sandhya

[email protected]

International Journal of Allied Medical Sciences and Clinical Research, Vol. 11 No. 3 (2023): 2023 Volume -11 - Issue 3

Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Pseudoephedrine and Loratadine , in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex Luna C18 (4.6×150mm, 5µ) column using a mixture of Acetonitrile: Water (10:90% v/v) as the mobile phase at a flow rate of 0.9ml/min, the detection was carried out at 240nm. The retention time of the Pseudoephedrine and Loratadine  was 1.933, 3.396±0.02min respectively. The method produce linear responses in the concentration range of 16.5-82.5mg/ml of Pseudoephedrine and 5-25mg/ml of Loratadine . The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords

Pseudoephedrine Loratadine RP-HPLC validation
References
  1. Dr. Kealey, Haines PJ. Analytical chemistry. 1st ed. Bios Publisher; 2002. P. 1-7.
  2. BraithWait A, Smith FJ. Chromatographic methods. 5th ed. Kluwer Academic Publishers; 1996. P. 1-2.
  3. Weston A, Phyllisr. Brown, HPLC principle and practice. 1st ed. Academic press; 1997. P. 24-37.
  4. Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. Wiley Interscience A JohnWiley & Sons, Inc Publishing House; 2007. P. 15-23.
  5. Chromatography [online]. Wikipedia. Available from: http://en.wikipedia.org/wiki/Chromatography.
  6. Meyer VR. Practical high-performance liquid chromatography. 4th ed. England: John Wiley & Sons Ltd; 2004. P. 7-8.
  7. Sahajwalla CG a new drug development. Vol. 141. New York: Marcel Dekker, Inc; 2004. P. 421-6.
  8. Introduction to column [online]. Available from: http://amitpatel745.topcities.com/index_files/study/columncare.pdf.
  9. Detectors used in HPLC (online). Available from: http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC.
  10. Detectors [online]. Available from: http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html.
  11. Detectors [online]. Available from: http://www.dionex.com/enus/webdocs/64842-31644-02_PDA-100.pdf.
  12. Detectors [online]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/8867705.
  13. Detectors [online]. Available from: http://www.chem.agilent.com/Library/applications/59643559.pdf.
  14. Detectors [online]. Available from: http://hplc.chem.shu.edu/new/hplcbook/detector.
  15. Draft ICH. Guidelines on Validation of Analytical Procedures Definitions and terminology. Fed Regist. 1995;60:1126.
  16. Code. Q2B, validation of analytical procedures; methodology. ICH harmonized tripartite guidelines. 1996:1-8.
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