K. Bhavya Sri, Maimuna Begum, Narmada, Mogili Sumakanth
K. Bhavya Sri*, Maimuna Begum, Narmada, Mogili Sumakanth
Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad, India.
Volume - 16,
Issue - 2,
Year - 2023
A simple, accurate, precise and rapid reverse phase high performance liquid chromatography method was developed and validated for the analysis of venlafaxine hydrochloride in bulk and marketed pharmaceutical dosage form. The chromatographic separation was carried out using a Phenomenex C18, (250mm × 4.6mm × 5µ) column. The optimum mobile phase consisted of ammonium acetate buffer, methanol (60:40) with pH adjusted to 5. The mobile phase was delivered isocratically at a flow rate of 1mL/min with UV detection at 227nm. Venlafaxine hydrochloride was eluted at 2 minutes. The method was validated for linearity, precision, accuracy, robustness and recovery. The method was linear in the concentration range of 15-165µg/ml with correlation coefficient 0.9997. limit of detection and limit and quantification were found to be 185ng/ml and 563ng/ml respectively.
Cite this article:
K. Bhavya Sri, Maimuna Begum, Narmada, Mogili Sumakanth. Development and Validation of a RP-HPLC Method for the determination of Venlafaxine hydrochloride in bulk and Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology 2023; 16(2):524-8. doi: 10.52711/0974-360X.2023.00089
K. Bhavya Sri, Maimuna Begum, Narmada, Mogili Sumakanth. Development and Validation of a RP-HPLC Method for the determination of Venlafaxine hydrochloride in bulk and Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology 2023; 16(2):524-8. doi: 10.52711/0974-360X.2023.00089 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-2-8
1. Holliday SM, Benfield P. Venlafaxine. A review of its pharmacology and therapeutic potential in depression. Drugs. 1995 Feb;49(2):280-94. doi: 10.2165/00003495-199549020-00010. PMID: 7729333.
2. European Pharmacopoeia. Council of Europe. European Pharmacopoeia: Supplement 6.1. 6th ed. Strasbourg: Council of Europe; 2008.
3. The British Pharmacopoeia (BP). England: Stationery Office;2008.
4. Liu Y, Sun Y, Sun J, Zhao N, Sun M, He Z. Preparation and in vitro/in vivo evaluation of sustained-release venlafaxine hydrochloride pellets. Int J Pharm. 2012 Apr 15;426(1-2):21-28. doi: 10.1016/j.ijpharm.2011.12.053. Epub 2012 Jan 14. PMID: 22266529.
5. Steven M. Troy, Clifford Dilea, Patrick T. Martin, Amy S. Rosen, Richard J. Fruncillo, Soong T. Chiang, Bioavailability of once-daily venlafaxine extended release compared with the immediate-release formulation in healthy adult volunteers, Current Therapeutic Research, 1997, 58 (8), 492-503, doi.org/10.1016/S0011-393X(97)80041-0.
6. Makhija SN, Vavia PR. Once daily sustained release tablets of venlafaxine, a novel antidepressant. Eur J Pharm Biopharm. 2002 Jul;54(1):9-15. doi: 10.1016/s0939-6411(02)00049-8. PMID: 12084497.
7. Smith D, Dempster C, Glanville J, Freemantle N, Anderson I. Efficacy and tolerability of venlafaxine compared with selective serotonin reuptake inhibitors and other antidepressants: a meta-analysis. Br J Psychiatry. 2002 May; 180:396-404. doi: 10.1192/bjp.180.5.396. PMID: 11983635
8. ICH Harmonised Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2 (R1)
9. Raut BB, Kolte BL, Deo AA, Bagool MA, Shinde DB. A rapid and sensitive high performance liquid chromatographic method for determination of venlafaxine and o-desmethyl venlafaxine in human plasma with UV detection. J LiqChromatogrTechnol2003; 26:1297- 313.
10. ICH, Q2A Text on validation of analytical procedures, international conference on harmonization, Oct, 1994.
11. ICH, Q3B validation of analytical procedures: methodology, international conference on harmonization, Nov, 1996.
12. Yardley JP, Husbands GE, Stack G, Butch J, Bicksler J, Moyer JA, Muth EA, Andree T, Fletcher H, James MN. 2-Phenyl-2-(1-hydroxycycloalkyl) ethylamine derivatives: synthesis and antidepressant activity. Journal of Medicinal Chemistry, 33 (10), 1990, 2899-905.
13. Yardley JP, Husbands GE, Stack G, Butch J, Bicksler J, Moyer JA, Muth EA, Andree T, Fletcher H, James MN. 2-Phenyl-2-(1-hydroxycycloalkyl) ethylamine derivatives: synthesis and antidepressant activity. Journal of Medicinal Chemistry, 33 (10), 1990, 2899-905.
14. Baldania SL, Bhatt KK, Mehta RS, Shah DA, Gandhi TR. RP-HPLC estimation of venlafaxine hydrochloride in tablet dosage forms. Indian J. Pharm. Sci., 70(1), 2008, 124-128.
15. Matoga M, Pehoureq F. Rapid HPLC measurement of Venlafaxine and O-desmethyl Venlafaxine in Human plasma. J.chromatogra B Biomed Sci Apl, 760, 2001, 213-218.
16. Sethi P D, High Performance Liquid Chromatography–Quantitative analysis of Pharmaceutical Formulations, 1st Ed., CBS Publishers & Distributors, New Delhi, India, 2001
17. Rao N R and Raju N A, J Sep Sci., 2006, 29(18), 2733-2744.
18. We, L., Feng, W., Huan-de, L., “Simultaneos stereoselective analysis of Venlafaxine and Odesmethyl venlafaxine enantiomers in human plasma by HPLC-ESI/MS using a vancomycin chiral column” J. Chromatogr. B, 850, 183-189, 2007.
19. Charlote, D., Grandmaison, de la., Lorin, G., Mazancourt, D. jean-Claude, A., “A High-Performance Liquid Chromatography Method with photodiode array UV detection for therapeutic drug monitoring of the nontricyclic antidepressant drugs” Therapeutic Drug Monitoring, 25, 565-573, 2003.
20. Dalletm, P., Labat, M., Richard, M., Langlois, H., Dubost, P., “A reversed phase HPLC method development for the separation of new antidepressants” J. Liq. Chromatogr. Rel. Technol., 25, 101-111, 2002