Comprehensive Review on Analytical Profile of Antidepressant Drug
Venlafaxine is an antidepressant belonging to a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Venlafaxine affects chemicals in the brain that may be unbalanced in people with depression. It is used to treat major depressive disorder, anxiety and panic disorder. The present review assesses the various approaches for analysis of Venlafaxine in bulk drug as well as various formulations. A concise review represents the compilation and discussion of about more than 35 analytical methods which includes HPLC, HPTLC, UPLC, LC-MS and UV-Spectrophotometry methods implemented for investigation of Venlafaxine in biological matrices, bulk samples and in different dosage formulations. This detailed review will be of great help to the researcher who is working on Venlafaxine.
Keywords: Venlafaxine; Analytical Profile; HPLC; HPTLC; Bioanalytical; Stability indicating
2. Rao BK, Manjula KR, Babu KS, Rambabu C. Validation of stability indicating RP-HPLC method for the assay of venlafaxine in pharmaceutical dosage form. Pharm Lett. 2015;7:247-56.
3. Somasekhar V, Gowrisankar D, Shivakumar HN. Development and validation of a rapid RP-HPLC method for the determination of venlafaxine hydrochloride in pharmaceutical dosage forms using experimental design. Journal of Chemistry. 2009;6(4):1091-102.
4. Nageswara Rao R, Narasa Raju A. Simultaneous separation and determination of process‐related substances and degradation products of venlafaxine by reversed‐phase HPLC. Journal of separation science. 2006 Dec;29(18):2733-44.
5. Siddiqui MR, AlOthman ZA, Rahman N. Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of chemistry. 2017 Feb 1;10:S1409-21.
6. Samanidou V, Nazyropoulou C, Kovatsi L. A simple HPLC method for the simultaneous determination of venlafaxine and its major metabolite O-desmethylvenlafaxine in human serum. Bioanalysis. 2011 Aug;3(15):1713-8.
7. Asafu-Adjaye EB, Faustino PJ, Tawakkul MA, Anderson LW, Lawrence XY, Kwon H, Volpe DA. Validation and application of a stability-indicating HPLC method for the in vitro determination of gastric and intestinal stability of venlafaxine. Journal of pharmaceutical and biomedical analysis. 2007 Apr 11;43(5):1854-9.
8. Kiran BV, Rao BS. and Som Shankar Dubey. Validation of Venlafaxine in Pharmaceutical Dosage by Reverse Phase HPLC Method. Journal of Pharmacy Research. 2012;5(5):2683-7.
9. Peikova L, Ivanka P, and Vanita M. Development of HPLC method for determination of Venlafaxine during concomitant use of metoprolol. Pharmacia 60 (2013):12-16.
10. Younus M, Arif MF, Richards MP, Kumar B. Determination of venlafaxine and modafinil in individual tablet dosage forms using single RP-HPLC method. Tropical Journal of Pharmaceutical Research. 2013;12(2):239-45.
11. Liu W, Dai YC, Deng N, Liu XR, Luo Y. Development and validation of a HPLC‐MS/MS method for the determination of venlafaxine enantiomers and application to a pharmacokinetic study in healthy Chinese volunteers. Biomedical Chromatography. 2011 Mar;25(3):412-6.
12. Kumar KS, Samnani PB. Development and Validation of a New HPLC Method for Simultaneous determination of Esomeprazole, Venlafaxine HCl and Fenofibrate. Int. J. Chem. Tech. Res. 2014 Jan;6(1):838-44.
13. Nageswara Rao R, Narasa Raju A. Simultaneous separation and determination of process‐related substances and degradation products of venlafaxine by reversed‐phase HPLC. Journal of separation science. 2006 Dec;29(18):2733-44.
14. Panchumarthy R, Anusha RK, and Devadasu C. Development and validation of isocratic RP-HPLC method for determination of venlafaxine bulk and tablet dosage form.
15. Malik A, Firke SD, Patil RR, Shirkhedkar AA, Surana SJ. Determination of iron chelating agents by analytical methods: a review. Critical reviews in analytical chemistry. 2019 May 27:1-1.
16. Guideline, ICH Harmonised Tripartite. "Text on validation of analytical procedures." International Conference on Harmonization, Geneva. 1994.
17. Karani NA, Pingale P. Analytical method development & validation of venlafaxine hydrochloride in solid dosage forms using UV spectrophotometer. J Pharma Res. 2009;2:1246-9.
18. Pakhale BA, Shinkar DM, Saudagar RB. "Development and Validation of Spectrophotometric Method for Determination of Venlafaxine Hydrochloride.” International journal of Pharma sciences and research. 2015 Jan;6(1)
19. Eswarudu MM, Anitha V, Babu PS. New simple UV spectrophotometric method for determination of venlafaxine hydrochloride in pure and pharmaceutical formulation. World journal of pharmacy and pharmaceutical sciences. 2017 May;6(7):1292-1300
20. Sowmya C, Reddy YP, Kumar MK, Raja MS. Development and validation of spectrophotometric method for the estimation of venlafaxine in bulk and formulations. International Journal of Chemical Sciences. 2011;9(1):52-8.
21. Rathore GS, Basniwal PK, Suthar M, Gupta RN. Spectrophotometric estimation of Venlafaxine hydrochloride. Asian Journal of Chemistry. 2009 Sep 10;21(8):5908.
22. Raghubabu K, Swarup LS, Kalyanaramu B, Rao MN, Ramdas C. Simple and inexpensive methods development for determination of venlafaxine hydrochloride from its solid dosage forms by visible spectrophotometry. Journal of Chemistry. 2012 Apr 3;9(3):1645-
23. Hosseini M. Application of UV-Spectrophotometry and HPLC for determination of Venlafaxine and its four related substances in pharmaceutical dosage forms. Turk J. Pharm. Sci. 2011 Jul 1;8(2):91-104.
24. Dave K, Desai S. Factorial design for development of a high-performance thin-layer chromatography method for the simultaneous estimation of abacavir sulfate, lamivudine hydrochloride, and dolutegravir sodium. JPC-Journal of Planar Chromatography-Modern TLC. 2018 Dec;31(6):489-95.
25. Redasani, VK, Patel PR, and Surana SJ. "Development and Validation of Venlafaxine Hydrochloride in Bulk and in Capsule Formulation by HPTLC." Journal Analytical and pharmaceutical research 4.2 (2017): 00103.
26. Jain A, Parashar AK, Nema RK, Narsinghani T. High Performance Thin Layer Chromatography (HPTLC): A Modern Analytical Tool for Chemical Analysis. Current Research in Pharmaceutical Sciences. 2014 Mar 30:8-14.
27. Phoujdar M, Maske S, and Kenghe N. "Development and validation of HPTLC method for determination of venlafaxine HCl in API and pharmaceutical dosage form." World journal of pharmaceutical research. 2015 March 4(4):1590-1598
28. Shirvi V, Channabasavaraj K, Kumar G, Mani T. HPTLC analysis of venlafaxine hydrochloride in the bulk drug and tablets. JPC-Journal of Planar Chromatography-Modern TLC. 2010 Oct 1;23(5):369-72.
29. Bakshi M, Singh S. Development of validated stability-indicating assay methods—critical review. Journal of pharmaceutical and biomedical analysis. 2002 Jun 15;28(6):1011-40.
30. Dolan JW. Stability-indicating assays. LC GC North America. 2002;20(4):346-9.
31. Smela JW. Regulatory considerations for stability indicating analytical methods in drug substance and drug product testing. Am. Pharm. Rev. 2005;8(3):51-4.
32. Blessy MR, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. Journal of pharmaceutical analysis. 2014 Jun 1;4(3):159-65.
33. Guideline IH. Stability testing of new drug substances and products. Q1A (R2), current step. 2003 Feb;4:1-24.
34. Guideline IH. Stability testing: photostability testing of new drug substances and products. Q1B, Current Step. 1996;4.
35. Guideline IH. Validation of analytical procedures: text and methodology Q2 (R1). International conference on harmonization, Geneva, Switzerland 2005 Nov 10 (Vol. 11).
36. Kaur J, "Development and validation of stability indicating method for the quantitative determination of venlafaxine hydrochloride in extended release formulation using high performance liquid chromatography." Journal of Pharmacy and Bioallied Sciences 2.1 (2010): 22
37. Srinivas CS, Devi RP, Gampa V. Stability indicating method of related impurities in venlafaxine hydrochloride sustained release tablets. Int J Adv Pharma Sci. 2010;1(2):177-83.
38. Rao KV, Reddy KP, Kumar YR. Stability indicating LC method for rapid determination of related substances of O-desmethyl venlafaxine in active pharmaceutical ingredients and pharmaceutical formulations. Journal of chromatographic science. 2014 Nov 1;52(10):1247-54.
39. Makhija SN, Vavia PR. Stability indicating LC method for the estimation of venlafaxine in pharmaceutical formulations. Journal of pharmaceutical and biomedical analysis. 2002 Jun 15;28(6):1055-9.
40. Bernardi LS. "Development and validation of a stability-indicating method for the determination of venlafaxine in extended-release capsules and dissolution kinetic studies." Journal of chromatographic science 47.9 (2009): 770-776.
41. Dubey SK, Anand A, Saha RN. Stability indicating high performance thin layer chromatographic method for quantitation of venlafaxine in bulk and pharmaceutical dosage form. Drug Development and Therapeutics. 2015 Jan 1;6(1):33.
42. Ramesh B, Narayana P, Reddy A, Devi P. Stability-indicating HPTLC method for analysis of venlafaxine hydrochloride, and use of the method to study degradation kinetics. JPC-Journal of Planar Chromatography-Modern TLC. 2011 Apr 1;24(2):160-5.
43. Tiwari G, Tiwari R. Bioanalytical method validation: An updated review. Pharmaceutical methods. 2010 Oct 1;1(1):25-38.
44. Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A. Bioanalytical method validation—a revisit with a decade of progress. Pharmaceutical research. 2000 Dec 1;17(12):1551-7.
45. Matoga M, Pehourcq F, Titier K, Dumora F, Jarry C. Rapid high-performance liquid chromatographic measurement of venlafaxine and O-desmethylvenlafaxine in human plasma: application to management of acute intoxications. Journal of Chromatography B: Biomedical Sciences and Applications. 2001 Sep 5;760(2):213-8.
46. Liu W, Wang F. Simultaneous stereoselective analysis of venlafaxine and O-desmethylvenlafaxine enantiomers in human plasma by HPLC-ESI/MS using a vancomycin chiral column. Journal of Chromatography B. 2007 May 1;850(1-2):183-9.
47. Liu W, Wang F. Simultaneous stereoselective analysis of venlafaxine and O-desmethylvenlafaxine enantiomers in human plasma by HPLC-ESI/MS using a vancomycin chiral column. Journal of Chromatography B. 2007 May 1;850(1-2):183-9.
48. Qin F, Li N, Qin T, Zhang Y, Li F. Simultaneous quantification of venlafaxine and O-desmethylvenlafaxine in human plasma by ultra performance liquid chromatography–tandem mass spectrometry and its application in a pharmacokinetic study. Journal of Chromatography B. 2010 Mar 1;878(7-8):689-94.
49. Shah GR, Thaker BT, Surati KR, Parabia MH. Simultaneous determination of venlafaxine and its main active metabolite O-desmethyl venlafaxine in rat plasma by LC-MS/MS. Analytical sciences. 2009 Oct 10;25(10):1207-10.
50. Dziurkowska E, Wesolowski M. Simultaneous quantitation of venlafaxine and its main metabolite, O‐desmethylvenlafaxine, in human saliva by HPLC. Journal of separation science. 2013 Jun;36(11):1726-33.
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