Stability indicating dissolution analytical method validation of Venlafaxine in pellets by UV-spectrophotometer
Abstract
To develop & validate new dissolution analytical method for venlafaxine in pellets by uv-spectrophotometer Solubility determination of venlafaxine in 0.1N HCl, Determine the absorption maxima of the drug in UV-Visible region in 0.1N HCl , Develop a new dissolution analytical method for venlafaxine in pellets by uv-spectrophotometer ,Validate the developed method as per ICH guidelines. The current good manufacturing practices (CGMP) and the Food Drug Administration (FDA) guidelines insist for adoption of sound methods of analysis with greater sensitivity and reproducibility. Therefore, the complexity of problems encountered in pharmaceutical analysis with the importance of achieving the selectivity, speed, low cost, simplicity, sensitivity, specificity, precision and accuracy in estimation of drugs.
Keywords:
venlafaxine, UV-spectrophotometer, HCl, CGMP, FDA
References
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24. Vijaya Bharathi R, Raju M.K, Susmitha U, Raghavendra V, Parajuli D, Suryanarayana B, Yonatan Mulushoa S, Murali N, Samatha K. Cu2+ substituted Mg-Co ferrite has improved dc electrical resistivity and magnetic properties. Inorganic Chemistry Communications. 2023 March 1; 149: 110452-8. https://doi.org/10.1016/j.inoche.2023.110452.
25. Rambabu Ch, Susmitha U, Ritesh V, Ramakrishna A, Murali N, Shivanarayana Ch, Parajuli D, Suryanarayana B, Batoo KM, Sajjad H, Lakshmi Narayana PV. Effect of La3+and Ni2+ substitution on Sr1-xLaxFe12-yNiyO19 hexaferrite structural, magnetic, and dielectric properties. Materials Science and Engineering: B. 2023 March; 289: 116257-64, https://doi.org/10.1016/j.mseb.2022.116257.
26. Monika Bakshi and Saranjit Singh. Establishment of inherent stability of secnidazole and development of a validated stability-indicating high-performance liquid chromatographic assay method. Journal of Pharmaceutical and Biomedical Analysis. 19 November 2004, 36(4), 769-775.
27. Sriram N, Susmitha U, Kavitha R, Someshwaran S, Senthil Kumar B, Prasad PN, Shanta KA. Cognitive Enhancing and Antioxidant Activity Of Ethyl Acetate Soluble Fraction Of The Methanol Extract of Pisonia Alba Leaves In Scopolamine-Induced Amnesia. Journal of Pharmaceutical Negative Results. 2022 Dec. 1 [cited 2023 Feb. 15]; 3740-9. https://pnrjournal.com/index.php/home/article/view/4189
28. Purnachandra reddy G, Sriram N, Sarad Pawar Naik B, Kiran Kumar Y, Parameshwar H, Saravanan J, Susmitha U. Formulation and Evaluation of Sustained Release Matrix Tablets Of Glimipride Using Natural Polymers Tamarind Seed Mucilage And Guar Gum. Journal of Pharmaceutical Negative Results. 2022 Dec. 13 [cited 2023 Feb. 15]; 5256-67. https://pnrjournal.com/index.php/home/article/view/4615
29. Abdel Fattah M. El Walily, Heba H. Abdine, Omayma Abdel Razak and Saad Zamel. Spectrophotometric and HPLC determination of secnidazole in pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis. July 2000, 22(6), 887-897.
2. Dr.S.Ravi Sankar, “Text Book of Pharmaceutical Analysis”, 5th Edition, Rx Publications, Tirunelveli, 2006, p 13(1)-13(3), 18(8), 18(10).
3. HPLC seminar by Jasco international Co., Ltd.
4. Lloyd R.Snyder; Joseph J. Kirkland; Joseph L.Glajch, “Practical HPLC Method Development”, 2nd Edition, A wiley Interscience Publication, John willey & sons, INC., United States of America, 1997, P 208-210, 685-710.
5. United States Pharmacopoeia <1225>
6. R.J.Hamilton; P.A.Sewell, “Introduction to High Performance Liquid Chromatography”, 2nd Edition J.W.Arrowsmith Ltd., Bristol, Great Britain, 1982, p 42-78.
7. A.Pryde; M.T.Gilbert, “Applications of High Performance Liquid Chromatography”, 1st Edition, Champman and Hall in association with Methuen, New York, New York, 1980, p 13-19.
8. Sathish Mohan B, Seetharam P, Manga Raju I, Suresh P, Satyanarayana G, Sangaraju S, Susmitha U, Tejeswararao D. Nanohybrid material of Co–TiO2 and optical performance on methylene blue dye under visible light illumination. Hybrid Advances. 2022 Dec 1; 1: 100008-16. https://doi.org/10.1016/j.hybadv.2022.100008
9. H.Engelhardt, “Practice of High Performance Liquid Chromatography”, 1st Edition, Springer-Verlog Berlin, Heidelberg, 1986, p 27.
10. Gurdeep R.Charwal; Sham K.Anand, “Instrumental Methods of Analysis”, 4th Edition, Shing Hanse, Mumbai, 2006, p 2.624-2.631.
11. Holler; Skoog; Crouch, “Principles of Instrumental Analysis”, 6th Edition, Baba Barkha Nath Printers, Haryana, 2007, p 818-828.
12. HPLC principles by Renk, p 174-182.
13. www.ich.org .in.
14. British Pharmacopiea -2007 , vol-2 pg no:2144.
15. http://www.madeinchina.com/2226978/P4941704/Secnidazole.shtml
16. http://www.seqchem.com/safetysheet.php?SQIndex=SRP010965s
17. Parajuli D, Susmitha U, Murali N, Ramakrishna A, Suryanarayana B, Samatha K. Synthesis and characterization MXene-Ferrite nanocomposites and its application for dying and shielding. Inorganic Chemistry Communications. 2023 Feb; 148: 110319-33. https://doi.org/10.1016/j.inoche.2022.110319
18. SL Baldania1, KK Bhatt, RS Mehta, DA Shah, Tejal R Gandhi. RP-HPLC estimation of venlafaxine hydrochloride in tablet dosage forms. Indian Journal of Pharmaceutical Sciences,Year : 2008, 70, 124-128.
19. Aspreet Kaur, KK Srinivasan, Alex Joseph, Abhishek Gupta, Yogendra Singh, Kona S Srinivas, Garima Jain. 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 & Bioallied Sciences. 2010(2), 22-26.
20. 18. Development and Validation of a Rapid HPLC Assay for the Simultaneous Determination. Journal of Liquid Chromatography & Related Technologies. March 2008 , 31 (5), 722-732.
21. Nagasree K.L.V, Suryanarayana B, Raghavendra V, Susmitha U, Tulu Wegayehu M, Kavyasri D, Murali N, Raju M.K, Parajuli D, Samatha K. Influence of Mg2+ and Ce3+ substituted on synthesis, structural, morphological, electrical, and magnetic properties of Cobalt nano ferrites. Inorganic Chemistry Communications. 2023 March; 149: 110405-12 https://doi.org/10.1016/j.inoche.2023.110405.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.
22. He Juan, Zhou Zhiling and Li Huande. Simultaneous determination of fluoxetine, citalopram, paroxetine, venlafaxine in plasma by high performance liquid chromatography–electrospray ionization mass spectrometry (HPLC–MS/ESI). Journal of Chromatography B. June 2005, 820(1), 5 33-39.
23. Wen Liu, Feng Wang and Huan-de Li. Simultaneous stereoselective analysis of venlafaxine and O-desmethylvenlafaxine enantiomers in human plasma by HPLC-ESI/MS using a vancomycin chiral column, Journal of Chromatography. May 2007, 850(1-2), 183-189.
24. Vijaya Bharathi R, Raju M.K, Susmitha U, Raghavendra V, Parajuli D, Suryanarayana B, Yonatan Mulushoa S, Murali N, Samatha K. Cu2+ substituted Mg-Co ferrite has improved dc electrical resistivity and magnetic properties. Inorganic Chemistry Communications. 2023 March 1; 149: 110452-8. https://doi.org/10.1016/j.inoche.2023.110452.
25. Rambabu Ch, Susmitha U, Ritesh V, Ramakrishna A, Murali N, Shivanarayana Ch, Parajuli D, Suryanarayana B, Batoo KM, Sajjad H, Lakshmi Narayana PV. Effect of La3+and Ni2+ substitution on Sr1-xLaxFe12-yNiyO19 hexaferrite structural, magnetic, and dielectric properties. Materials Science and Engineering: B. 2023 March; 289: 116257-64, https://doi.org/10.1016/j.mseb.2022.116257.
26. Monika Bakshi and Saranjit Singh. Establishment of inherent stability of secnidazole and development of a validated stability-indicating high-performance liquid chromatographic assay method. Journal of Pharmaceutical and Biomedical Analysis. 19 November 2004, 36(4), 769-775.
27. Sriram N, Susmitha U, Kavitha R, Someshwaran S, Senthil Kumar B, Prasad PN, Shanta KA. Cognitive Enhancing and Antioxidant Activity Of Ethyl Acetate Soluble Fraction Of The Methanol Extract of Pisonia Alba Leaves In Scopolamine-Induced Amnesia. Journal of Pharmaceutical Negative Results. 2022 Dec. 1 [cited 2023 Feb. 15]; 3740-9. https://pnrjournal.com/index.php/home/article/view/4189
28. Purnachandra reddy G, Sriram N, Sarad Pawar Naik B, Kiran Kumar Y, Parameshwar H, Saravanan J, Susmitha U. Formulation and Evaluation of Sustained Release Matrix Tablets Of Glimipride Using Natural Polymers Tamarind Seed Mucilage And Guar Gum. Journal of Pharmaceutical Negative Results. 2022 Dec. 13 [cited 2023 Feb. 15]; 5256-67. https://pnrjournal.com/index.php/home/article/view/4615
29. Abdel Fattah M. El Walily, Heba H. Abdine, Omayma Abdel Razak and Saad Zamel. Spectrophotometric and HPLC determination of secnidazole in pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis. July 2000, 22(6), 887-897.
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How to Cite
M, G., M, D., M, V., V, S., P, S., & P, S. (2023). Stability indicating dissolution analytical method validation of Venlafaxine in pellets by UV-spectrophotometer. Journal of Integral Sciences, 6(2), 58-62. https://doi.org/10.37022/jis.v6i2.58
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