RP-HPLC stability indicating method development for the estimation of drug marketed formulation
Keywords:
RP-HPLC, Olanzapine, ICH, ANDA, NDAAbstract
In this study our idea is to developed RP-HPLC method for analysis and method of development for pure drug and their pharmaceutical formulation and their stability indicating its RP-HPLC method. It is used to validate and analysis for olanzapine drugs. By RP-HPLC method the drug olanzapine passes through various quality test and ensure the identity, strength, quality, purity and potency of the drug substance and drug products.
Downloads
References
Sethi P.D.; HPLC: Quantitative Analysis of Pharmaceutical Formulation; CBS Publishers and Distributors, New Delhi; 1996; 113-202.
Davidson A.G., Beckett A.H. and Stenlake J.B.; Practical Pharmaceutical Chemistry; 4th edition; CBS Publishers and Distributors, New Delhi; 1989; 276-99.
Jeffery G.H., Bassett J., Mendham J. and Denrey R.C.; Vogel's Textbook of Quantitative Chemical Analysis; 5th edition; Longman Group UK Ltd, England; 1989; 6-14.
http,//www. youngincom/application/AN-0608-0115ENpdf.
Swarbrick, James B. and James. C.; Encyclopedia of pharmaceutical technology; Volume I; Marcel Dekker Inc., New York; 1998; 217 - 224.
Sahu R. Nagar P. and Jain D.; Indian J. Pharm. Science; 2006; 68(4); 503-506.
Jain N., Jain R., Swami H. and Pandey S.; Indian Journal of Pharmacy and Pharmaceutical sciences ;volume1;Issue1;July-Sept 2009;189-191.
Khan, M.R. and Jain, D.; Indian Journal of Pharmaceutical sciences; 2006;64(6);546-548.
Meyer Veronica R.; Practical High Performance Liquid Chromatography; 2nd edition, John wiley and sons, London;1993;56-58.
Braumann T., Weber G. and Grimme L.H.; J.Chromatogr; 1983;48-65.
Snyder L.R.; Dolan J.W. and Dolan J.W.; J.Chromatogr; 1989; 48-65.
Aitzemuller K.; Practice of High Performance Liquid Chromatography, springer –Verlag; 1986; 301.
SGE International Pty. Ltd, TA-0010-H, 2001.
FDA; Draft Guidance for Industry, Stability Testing of Drug Substances and Drug Products; (FDA, Rockville, MD, June 1998); glossary.
ICH; Guidance for Industry, Q1A(R2); Stability Testing of New Drug Substances and Products; November; 2003; 1-17.
European Council (1993) Directive 93/42/EEC of 14 June 1993.
European Council (1990) Directive 90/385/EEC of 20 June 1990 on active implantable medical devices. Chapter 8 References Lakshmi Narain College of Pharmacy, Bhopal (M.P.) Page 58
Dan W., Reynolds Kevin L., Facchine June F. and Mullaney; Conducting Forced Degradation Studies; Pharmaceutical Technology;2002.
FDA; ICH: Guideline on the Validation of Analytical Procedures: Methodology, Availability, Notice; Federal Register 62 (96); 19 May 1997; 27463–27467.
Conners K.A., G.L. Amidon, and Stella, V.L.; Chemical Stability of Pharmaceuticals; Wiley and Sons; New York; 2d Ed.; 1986; 375-384.
FDA; ICH: Guideline for the Photostability Testing of New Drug Substances and New Drug Products; ICH Q1B; Federal Register 62 (95); 16 May 1997; 27115–27122 .
FDA; Center for Drug Evaluation and Research; Submitting Documentation for the Stability of Human Drugs and Biologics; Rockville, MD; February 1987; 38.
FDA; ICH: Guideline on Impurities in New Drug Products; ICH Q3B; Federal Register (Notices); 62 (96); 19 May 1997; 27453–274561.
FDA; Draft Guidance for Industry, Stability Testing of Drug Substances and Drug Products FDA, Rockville, MD, June 1998; glossary.
FDA; ICH: Guidance on Q6A Specifications; ICHQ6A; Federal Register (Notices); 65 (251); 29 December 2000; 83041–83063.
Reynolds, DW; Forced degradation of pharmaceuticals; Am Pharm Rev 2004; 56–61.
Dolan J.W.; Stability-indicating assays; LCGC N Am; 2002; 20; 346–349.
Baertschi S.W.; Pharmaceutical stress testing: predicting drug degradation; Taylor & Francis, Boca Raton; 2005.
Yoshioka S. and Stella V.; Stability of drugs and dosage forms; Plenum Pub Corp; 2000.
Kanakapura Basavaiah, Anil kumar Urdigere Rangachar, and Kalsang Tharpa; Quantitative Determination of Olanzapine in Pharmaceutical Preparations by HPLC; J. Mex. Chem. Soc.; 2008; 52(2); 120-124.
A. Pathak and S.J. Rajput; Development of a Stability-Indicating HPLC Method for Simultaneous Determination of Olanzapine and Fluoxetine in Combined Dosage Forms; Journal of Chromatographic Science; Vol. 47; August 2009; 605-611.
Prameela Rani A. and Bala Sekaran C.; Development of HPLC method for the determination of olanzapine in bulk and dosage forms. International Journal of PharmTech Research Coden( USA); IJPRIF ISSN : 0974-4304; July-Sept 2009; Vol.1, No.3; 654-657.
Zhang Meng-qi, JIA Jing-ying, LU Chuan, et al; Development and validation of a liquid chromatography-isotope dilution tandem mass spectrometry for determination of olanzapine in human plasma and its application to bioavailability study; Acta Pharmaceutica Sinica 2010; 45 (6); 767-771.
Basavaiah K., Zenita O., Rajendraprasad N., Kalsang Tharpa and Vinay K.B.; Simple and sensitive spectrophotometric determination of olanzapine in pharmaceuticals using hexacyanoferrate (III) an improved protocol; Journal of Advanced Pharmaceutical Research; 2010, 1(2); 146-156.
Rubesh kumar S., P. Gayathri, Duganath N., Kiran C.H., Sridhar C. and Jayaveera K.N.; Simultaneous Estimation of Fluoxetine HCl and Olanzapine in Bulk Drug and Pharmaceutical Formulation by Using UV-VisibleSpectroscopy Method; International Journal of Pharmaceutical Sciences and Drug Research; 2011; 3(1); 52-55.
A. Rukmangada Rao, Delhi Raj N. and Jagadeesh; RP-HPLC method for Quantitative Estimation of Olanzapine in tablet Dosage forms; International Journal of Pharma and Bio Sciences; 2012 July; 3(3); 267 – 272.
Mahmoud A. Tantawy, Nagiba Y. Hassan, Nariman A. Elragehy and Mohamed Abdelkawy; Simultaneous determination of Olanzapine and Fluoxetine hydrochloride in capsules by spectrophotometry, TLC-spectrodensitometry and HPLC; Journal of Advanced Research 2013(4), 173–180.
Vilas Chaudhary and Milind Ubale; Simultaneous High-Performance Liquid Chromatographic Determination of Olanzapine hydrochloride in Pharmaceutical Dosage Form; International Journal of Advances In Pharmacy, Biology and Chemistry; Vol. 2(1); Jan- Mar, 2013; 57-62.
Published
How to Cite
Issue
Section
Copyright (c) 2022 International journal of health sciences
![Creative Commons License](http://i.creativecommons.org/l/by-nc-nd/4.0/88x31.png)
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Articles published in the International Journal of Health Sciences (IJHS) are available under Creative Commons Attribution Non-Commercial No Derivatives Licence (CC BY-NC-ND 4.0). Authors retain copyright in their work and grant IJHS right of first publication under CC BY-NC-ND 4.0. Users have the right to read, download, copy, distribute, print, search, or link to the full texts of articles in this journal, and to use them for any other lawful purpose.
Articles published in IJHS can be copied, communicated and shared in their published form for non-commercial purposes provided full attribution is given to the author and the journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
This copyright notice applies to articles published in IJHS volumes 4 onwards. Please read about the copyright notices for previous volumes under Journal History.