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Submitted
April 21, 2023
Published
April 21, 2023
A stability indicating rp-hplc method developement for the simultaneous determination of ketorolac and olopatadine in bulk and in its pharmaceutical dosage forms
Corresponding Author(s) : Y.Evangelin
kirn1987@gmail.com
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 2 (2023): 2023 Volume -11 - Issue 2
Abstract
A simple, rapid and precise reverse phase liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Ketorolac and Olopatadine. In this method an Symmetry C18, 250×4.6mm, (innertsil ODS). 5µ or equivalent in an isocratic mode utilizing Phosphate Buffer (4.6 pH): Acetonitrile (50:50%v/v) at a flow rate of 1.0 ml/ min and effluent was monitored at 219 nm. Olopatadine hydrochloride& Ketorolac tromethamine was 2.724, 3.849 minutes. The linearity range was found to be 25 to 150µl. The validated method was very linear and precise.
Keywords
ketorolac, olopatadine
Y.Evangelin, J.Ijeya, K.Sruthi, M.Sagar Babu, N.Hemanth Reddy, & S.Divya Sai Bhaskar. (2023). A stability indicating rp-hplc method developement for the simultaneous determination of ketorolac and olopatadine in bulk and in its pharmaceutical dosage forms. International Journal of Allied Medical Sciences and Clinical Research, 11(2), 129–135. https://doi.org/10.61096/ijamscr.v11.iss2.2023.129-135
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References
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References
1. Abdou HM. Dissolution, Bioavailability, Pennsylvania, Mack Publishing Company; 1989.
2. ACTOS (pioglitazone hydrochloride) tablet. Daily med current medication information.
3. AkulaThukaramBapuji HLVR et al. Bioequivalence testing – industry perspective. J Bioequivalence Bioavailability;2(5).
4. Shargel L, wu-Pong S, Andrew BCY. Applied Biopharmaceutics & pharmacokinetics. 5th ed.
5. Asian guidelines for ’the conduct of bioavailability and bioequivalence studies’, final draft: 21 July 2004. Adopted from ”note for guidance on the investigation of bioavailability and bioequivalence”, CPMP/EWP. London: European Agency for the Evaluation of Medicinal Products; July 26 2001/QWP/1401/98) with some adaptation for ASEAN application.
6. Bioavailability and bioequivalence requirements. Fed Regist. 1977;42:1624- 1653.
7. Bioavailability, chapter 8. Bioequivalence, and drug SelectionAuthor: RasmaChereson reviewer: UmeshBanakar.
8. Bioequivalence requirements guidelines. Kingdom of Saudi Arabia: Saudi Food and Drug Authority, Drug Sector [draft]; May 2005.
9. Brahmankar DM, Jaiswal SB. Bio pharmaceutics and pharmacokinetics à treatise published by M.K.Jain for wallabhprakashan, printed by goyal offset works, Delhi110088. 1st ed. p. 282-305.
10. CDER. Reviewer guidance. Validation Chromatogr Methods. 1994.
11. FDA. Guidance for industry. Anal Proc Methods Validation Chem Manuf Controls Doc, Draft Guidance. 2000.
12. Guidelines for Bioavailability and bioequivalence studies, Central Drugs Standard Control Organization, Directorate General of Health Services. New Delhi: Ministry of Health and Family Welfare, Government of India; March 2005.
2. ACTOS (pioglitazone hydrochloride) tablet. Daily med current medication information.
3. AkulaThukaramBapuji HLVR et al. Bioequivalence testing – industry perspective. J Bioequivalence Bioavailability;2(5).
4. Shargel L, wu-Pong S, Andrew BCY. Applied Biopharmaceutics & pharmacokinetics. 5th ed.
5. Asian guidelines for ’the conduct of bioavailability and bioequivalence studies’, final draft: 21 July 2004. Adopted from ”note for guidance on the investigation of bioavailability and bioequivalence”, CPMP/EWP. London: European Agency for the Evaluation of Medicinal Products; July 26 2001/QWP/1401/98) with some adaptation for ASEAN application.
6. Bioavailability and bioequivalence requirements. Fed Regist. 1977;42:1624- 1653.
7. Bioavailability, chapter 8. Bioequivalence, and drug SelectionAuthor: RasmaChereson reviewer: UmeshBanakar.
8. Bioequivalence requirements guidelines. Kingdom of Saudi Arabia: Saudi Food and Drug Authority, Drug Sector [draft]; May 2005.
9. Brahmankar DM, Jaiswal SB. Bio pharmaceutics and pharmacokinetics à treatise published by M.K.Jain for wallabhprakashan, printed by goyal offset works, Delhi110088. 1st ed. p. 282-305.
10. CDER. Reviewer guidance. Validation Chromatogr Methods. 1994.
11. FDA. Guidance for industry. Anal Proc Methods Validation Chem Manuf Controls Doc, Draft Guidance. 2000.
12. Guidelines for Bioavailability and bioequivalence studies, Central Drugs Standard Control Organization, Directorate General of Health Services. New Delhi: Ministry of Health and Family Welfare, Government of India; March 2005.
