UV-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DAPOXETINE HYDROCHLORIDE AND SILDENAFIL CITRATE IN TABLET DOSAGE FORM

Authors

  • Hemesh Gadiya Department of Quality Assurance, Geetanjali Institute of Pharmacy, Manwakhera NH-8 bypass, Udaipur, Rajasthan, India.
  • Monika Maheshwari Department of Quality Assurance, Geetanjali Institute of Pharmacy, Manwakhera NH-8 bypass, Udaipur, Rajasthan, India.
  • Ashok Dashora Department of Quality Assurance, Geetanjali Institute of Pharmacy, Manwakhera NH-8 bypass, Udaipur, Rajasthan, India.

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i1.29937

Keywords:

Sildenafil citrate, Dapoxetine hydrochloride, Simultaneous estimation, Ultraviolet spectrophotometric methods

Abstract

Objective: The objective of this research was to develop and validate a simple ultraviolet (UV) spectrophotometric method for simultaneous determination of sildenafil citrate and dapoxetine hydrochloride in a pharmaceutical formulation.

Methods: Two simple UV spectrophotometric methods have been developed for simultaneous determination of sildenafil citrate and dapoxetine hydrochloride. For both methods, stock solutions were prepared in methanol followed by the further required dilutions with methanol. Proposed dual-wavelength method and ratio derivative method, the wavelength of maximum absorption for sildenafil citrate and dapoxetine hydrochloride was 292 nm and 231 nm, respectively.

Results: In both methods, the linearity range lies between 10 and 60 μg/ml for sildenafil citrate and 2–12 μg/mL for dapoxetine hydrochloride with their respective wavelengths. By dual-wavelength method, the percentage of sildenafil citrate and dapoxetine hydrochloride was found to be 101.3% and 100.3%, respectively.

Conclusion: Result obtained in this research work clearly indicated that both these methods were found to be accurate, precise, stable, and robust as indicated by low values of percentage relative standard deviation. Thus, the present study gives an excellent method for the determination of both the drugs in combined tablet formulation.

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Author Biographies

Hemesh Gadiya, Department of Quality Assurance, Geetanjali Institute of Pharmacy, Manwakhera NH-8 bypass, Udaipur, Rajasthan, India.

Asssistant Professor, Department of Pharmaceutical Chemistry

Monika Maheshwari, Department of Quality Assurance, Geetanjali Institute of Pharmacy, Manwakhera NH-8 bypass, Udaipur, Rajasthan, India.

Research Scholar, Quality Assurance

Ashok Dashora, Department of Quality Assurance, Geetanjali Institute of Pharmacy, Manwakhera NH-8 bypass, Udaipur, Rajasthan, India.

Dean and Director, Department of Pharmacy

References

Kumar KA, Velmurugan R. Development and validation of UV spectroscopy method for the determination of dapoxetine hydrochloride in pharmaceutical formulation. J Pharm Res 2012;5:1949-51.

Giri AD, Bhasari VK, Dhaneshwar SR. HPLC method for simultaneous quantitation of tadalafil and dapoxetine hydrochloride in bulk drug and formulation qutanation. J Pharm Pharm Sci 2012;14:654-8.

Fronk AS. Handbook of Instrumental Techniques for Analytical Chemistry. 1st ed. London: Pearson Education; 2004. p. 121-49.

Swarbrick J, Boylan JC. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker Inc.; 1998. p. 217-24.

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

Banik S. A simple and rapid validated UV spectrophotometric method for estimation of dapoxetine in bulk and tablet dosage form. Indian J Novel Drug Deliv 2014;6:277-82.

Suruse SD, Jadhav KB. Dual wavelength spectrophotometric method for simultaneous estimation of telmisartan and indapamide in their combined dosage form. Int J Pharm Life Sci 2013;1:85-92.

Abdelwahab NS, Zeiny BA. Two spectrophotometric methods for simultaneous determination of some antihyperlipidemic drugs. J Pharm Anal 2012;2:279-84.

Palabiyik IM, Dinç E, Onur F. Simultaneous spectrophotometric determination of pseudoephedrine hydrochloride and ibuprofen in a pharmaceutical preparation using ratio spectra derivative spectrophotometry and multivariate calibration techniques. J Pharm Biomed Anal 2004;34:473-83.

FDA Guidance for Industry. Analytical Procedures and Method Validation, Chemistry, Manufacturing, and Controls Documentation, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER); 2000.

The United States Pharmacopeia. 35-National Formulary 30. Rockville, Md: The United States Pharmacopeial Convention; 2012. p. 260-5.

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

Baddenapalli T, Gandz V. Indirect spectrophotometric estimation of drugs using cerium (IV) and rhodamine-b as analytical reagents. Int J Pharm Pharm Sci 2015;8:62-6.

Kanani VV, Muralikrishna KS. Development and validation of UV spectrophotometric method for estimation of dapoxetine HCl in bulk and dosage form. Int J Drug Dev Res 2013;5:161-7.

Published

07-01-2019

How to Cite

Gadiya, H., M. Maheshwari, and A. Dashora. “UV-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DAPOXETINE HYDROCHLORIDE AND SILDENAFIL CITRATE IN TABLET DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, vol. 12, no. 1, Jan. 2019, pp. 328-31, doi:10.22159/ajpcr.2019.v12i1.29937.

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