HPLC DETERMINATION OF SILDENAFIL IN TABLETS

Authors

  • MIGLENA SMERIKAROVA Department of Chemistry, Faculty of Pharmacy, Medical University-Sofia
  • STANISLAV BOZHANOV Department of Chemistry, Faculty of Pharmacy, Medical University-Sofia, Sofia, Bulgaria
  • VANIA MASLARSKA Department of Chemistry, Faculty of Pharmacy, Medical University-Sofia, Sofia, Bulgaria

DOI:

https://doi.org/10.22159/ijap.2021v13i1.39719

Keywords:

Erectile dysfunction, Sildenafil, HPLC, Phosphodiesterase inhibitors, Tablets, Drugs

Abstract

Objective: The popularity of Sildenafil, the widespread distribution of various products and dietary supplements with added synthetic drugs, requires reliable analysis methods. This research study aimed to develop a simple isocratic HPLC method for the determination of Sildenafil in tablet dosage forms from the local market.

Methods: Separation was carried out at 30 °C, using column LiChrosorb® RP-18 (150 x 4.0 mm, 5 μm) with mobile phase consisting of acetonitrile: methanol: 0.5% triethylamine (15: 26: 59 v/v/v). The detector was set at 290 nm. The flow rate was 1.0 ml/min and the injection volume was 20 μl.

Results: Linear correlation was obtained within the range 6.25–50.0 μg/ml with correlation coefficient (R2) 0.9998. The achieved limits of detection and quantitation were 0.7 and 2.2 μg/ml, respectively.

Conclusion: The developed method can be applied for the quality control of Sildenafil preparations.

Downloads

Download data is not yet available.

References

Mitidieri E, Cirino G, d’ Emmanuele di Villa Bianca R, Sorrentino R. Pharmacology and perspectives in erectile dysfunction in man. Pharmacol Ther 2020;208:107493.

Dadomo H, Ponzi D, Nicolini Y, Volpi R, Palanza P, Pelosi A, et al. Loss of socio-economic condition and psychogenic erectile dysfunction: the role of temperament and depression. Adapt Hum Behav Physiol 2020;6:57-74.

Lee JH, Park HN, Park OR, Kim NS, Park SK, Hoil Kang H. Screening of illegal sexual enhancement supplements and counterfeit drugs sold in the online and offline markets between 2014 and 2017. Forensic Sci Int 2019;298:10-9.

Patel DN, Li L, Kee CL, Ge X, Low MY, Koh HL. Screening of synthetic PDE-5 inhibitors and their analogues as adulterants: analytical techniques and challenges. J Pharm Biomed Anal 2014;87:176-90.

Jiru M, Stranska-Zachariasova M, Dzuman Z, Hurkova K, Tomaniova M, Stepan R, et al. Analysis of phosphodiesterase type 5 inhibitors as possible adulterants of botanical-based dietary supplements: an extensive survey of preparations available at the Czech market. J Pharm Biomed Anal 2019;164:713-24.

Žuntar I, Krivohlavek A, Kosic Vuksic J, Granato D, Kovacevic DB, Putnik P. Pharmacological and toxicological health risk of food (herbal) supplements adulterated with erectile dysfunction medications. Curr Opin Food Sci 2018;24:9-15.

El-Amrawy F, El-Agouri G, Elnoweam O, Aboelazayem S, El-Mohanad F, Nounou MI. Adulterated and counterfeit male enhancement nutraceuticals and dietary supplements pose a real threat to the management of erectile dysfunction: a global perspective. J Diet Suppl 2016;13:660-93.

Rocha T, Amaral JS, Oliveira MBP. Adulteration of dietary supplements by the illegal addition of synthetic drugs: a review. Compr Rev Food Sci Food Saf 2016;15:43-62.

El-Gindy AE, Shokry E, Farouk M, Abd El-Aziz L. Validated methods for determination of sildenafil citrate in the presence of its potential impurities. J Biomed Sci Res 2010;2:262-78.

Sakur AA, Affas S. Validated spectrophotometric method to determine vardenafil and sildenafil in pharmaceutical forms using potassium iodide and potassium iodate. Int J Pharm Pharm Sci 2017;9:65-9.

Xiao S, He Y. Analysis of sildenafil in liquor and health wine using surface-enhanced Raman spectroscopy. Int J Mol Sci 2019;20:2722.

de Veij M, Deneckere A, Vandenabeele P, de Kaste D, Moens L. Detection of counterfeit viagra® with Raman spectroscopy. J Pharm Biomed Anal 2008;46:303–9.

Saeed SMA, Mohamed MA, Shantier SW, Gadkariem EA, Ismail EMO. Determination of undeclared sildenafil citrate and tadalafil in aphrodisiac herbal preparations by TLC and HPLC. Int J Innov Pharm Sci Res 2015;3:688-96.

Kannappan N, Yada D, Yada D, Shashikanth MR. Method development and validation of stability-indicating methods for assay of tadalafil and sildenafil citrate by HPLC. Int J Chemtech Res 2010;2:329-33.

Al-Amin M, Sultana GNN, Hossain CF. Identification of sildenafil citrate as an adulterant in herbal products using high-performance liquid chromatography with a photodiode array detector. Int J Pharm Pharm Sci 2018;10:15-20.

Sharma N, Rajput P, Thakkar A, Sarma GS. RP-HPLC method development for estimation of sildenafil citrate in tablets and in seminal fluid. J Appl Pharm Sci 2012;2:172-8.

Zaharieva Z, Tanev D, Danalev D. Development and validation of HPLC/DAD method for simultaneously determination of six prohibited substances in model matrices. Acta Chromatogr 2020;32:276-80.

Atipairin A, Woradechakul C, Chee KS, Sawatdee S, Yoon AS. Method validation for determination of sildenafil citrate in an extemporaneous oral suspension. Int J Pharm Pharm Sci 2014;6:131-6.

Ahmed NR, Lottfi SN. High performance liquid chromatographic method for determination of sildenafil citrate (Viagra) in pharmaceutical formulation and industrial effluent sample. Raf J Sci 2013;24:24-31.

Reddy BPK, Reddy YR. Validation and stability-indicating RP-HPLC method for the determination of sildenafil citrate in pharmaceutical formulations and human plasma. E J Chem 2008;5 Suppl 2:1117-22.

Tripathi AS, Sheikh I, Dewani AP, Shelke PG, Bakal RL, Chandewar AV, et al. Development and validation of RP-HPLC method for sildenafil citrate in rat plasma-application to pharmacokinetic studies. Saudi Pharm J 2013;21:317-21.

Dinesh ND, Vishukumar BK, Nagaraja P, Made Gowda NM, Rangappa KS. Stability indicating RP-LC determination of sildenafil citrate (Viagra) in pure form and in pharmaceutical samples. J Pharm Biomed Anal 2002;29:743-8.

Daraghmeh N, Al-Omari M, Badwan AA, Jaber AMY. Determination of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC. J Pharm Biomed Anal 2001;25:483-92.

Tracqui A, Ludes B. HPLC-MS for the determination of sildenafil citrate (Viagra) in biological fluids. Application to the salivary excretion of sildenafil after oral intake. J Anal Toxicol 2003;27:88-94.

Ozturk Er E, Ozbek E, Bakırdere S. Accurate and sensitive determination of sildenafil, tadalafil, vardenafil and avanafil in illicit erectile dysfunction medications and human urine by LC with quadrupole-TOF-MS/MS and their behaviors in simulated gastric conditions. J Sep Sci 2019;42:475–83.

Ozturk Er E, Akkaya E, Ozbek B, Bakırdere S. Development of an analytical method based on citric acid-coated magnetite nanoparticles assisted dispersive magnetic solid-phase extraction for the enrichment and extraction of sildenafil, tadalafil, vardenafil and avanafil in human plasma and urine prior to determination by LC-MS/MS. Microchem J 2019;147:269-76.

Ozturk Er E, Akkaya E, Ozbek B, Bakırdere S. A powerful combination of quadruple isotope dilution strategy with dispersive magnetic solid-phase extraction for the accurate and precise multi-analyte determination of tadalafil, sildenafil, avanafil and vardenafil in human plasma and urine samples using LC-ESI-tandem MS. Microchem J 2020;152:104302.

International Conference on Harmonization 2005 ICH harmonized tripartite guideline validation of analytical procedures: text and methodology Q2 (R1) ICH, Geneva; 2005.

Published

07-01-2021

How to Cite

SMERIKAROVA, M., BOZHANOV, S., & MASLARSKA, V. (2021). HPLC DETERMINATION OF SILDENAFIL IN TABLETS. International Journal of Applied Pharmaceutics, 13(1), 253–256. https://doi.org/10.22159/ijap.2021v13i1.39719

Issue

Section

Short Communication(s)