Development of Reverse Phase High Performance Liquid Chromatography Method for Simultaneous Estimation of Sildenafil Citrate and Depoxetine Hydrochloride in Pharmaceutical Formulation
Abstract
Simple, accurate and precise reversed-phase high-performance liquid chromatographic (RP-HPLC) methods for simultaneous estimation of sildenafil citrate (SIL) and depoxetine hydrochloride (DAP) in combined tablet dosage form have been developed and validated. The RP-HPLC method uses a Shimadzu – 1800, Software Version – UV Prob 2.33 with BDS hypersil C18 column and mixture of Buffer pH 4.0 and ACN in the ratio of 40:60 as the mobile phase. The detection was carried out using a UV–Visible Detector: Shimadzu SPD–20AT diode array detector set at 229 nm. Linearity of chromatographic method was found in the concentration range of 50 - 150 ppm for Sildenafil and 30 - 90 ppm for Dapoxetine respectively. % recovery for SIL was found to be 99.3 – 100.5 %, while for DAP it was found to be in range of 99.1 – 100.4 % in HPLC methods respectively. Both methods may be used for routine analysis of the drugs in a pharmaceutical formulation. Results of analysis were validated statistically.
References
2. Hobart H. Willard. Instrumental methods of analysis. CBS publishers & distributors, New delhi. 2004; 7th edition: PP:-1-5.
3. Mendham J, Denny RC, Barnes JD and Thomas MJK. Vogel’s Textbook of Quantitative Chemical Analysis. India: Dorling Kindersley (India) Pvt. Ltd. 2008; 6th ed.: pp 5-11, 244-271.
4. Kar A.: Pharmaceutical Drug Analysis. New age international Pvt Ltd., New Delhi. 2005; 2nd ed.: pp. 1-4, 452-467.
5. Skoog DA. and West DM. Principles of Instrumental Analysis. Sauners college, Philadelphia. 1980; 2nd ed: pp.1-4, 690-699.
6. Analytical Chemistry, 2012. Available from: www.en.wikipedia.org/wiki/Analytical chemistry.
7. Chatwal G. R. and Anand S.: Instrumetnal Methods of Chemical Analysis. Himalaya Publishing House, Mumbai. 2000: pp 180-98.
8. Brown P. and Deantonis K.: Handbook of Instrumental Techniques for Analytical Chemistry. Prentice Hall. Inc., New Jersey. 1997; F. (ed.): pp.2-7.147-157.
9. Sharma BK. Instrumental Method of Chemical Analysis. GOEL Publishing House, New Delhi. 2006; 25th ed.: pp 678-682, 2.625-2.639.
10. Okafo GN and Roberts JK. Development of achiral separation method in Pharmaceutical analysis. Wiley India Pvt. Ltd., New Delhi. 2008: pp 90, 31-48.
11. Munson JB. Pharmaceutical Analysis Modern Methods. International Medical Book Distributors, Mumbai. 2001: pp 378.
12. Willard HH, Merritt LL, Dean JA and Settle FA. Instrumental Method of Analysis. CBS Publishers and Distributors, New Delhi. 2001;7th ed.: pp 170.
13. “High-performance liquid chromatography”, November 2011. Available from:www.en.wikipedia.org/wiki/Highperformance liquid chromatography.
14. Schirmer RE. Modern Methods of Pharmaceutical Analysis. CRC Press, Floride. 2000; 2nd ed.: pp 67-72, 239-384.
15. Sethi PD. High Performance Liquid Chromatography: Quantitative Analysis of Pharmaceutical Formulations. CBS Publishers, New Delhi. 2001: p.13-4.
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