Determinaton of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC

N. Daraghmeh; M. Al-Omari; A. A. Badwan; A. M.Y. Jaber

doi:10.1016/S0731-7085(00)00512-4

Determinaton of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC

N. Daraghmeh
, M. Al-Omari
, A. A. Badwan
, A. M.Y. Jaber^*

^*Corresponding author for this work

King Fahd University of Petroleum & Minerals

Research output: Contribution to journal › Article › peer-review

95 Scopus citations

Abstract

This study aimed at developing and validating an HPLC method for the assay of sildenafil citrate and its related substances that might coexist in the drug commercial products and in tablets' formulation as impurities that originate from synthesis processes or degradation. A chromatographic system comprising a μBondapak C₁₈ (10 μm) column, a mobile phase of ammonium acetate (pH 7.0, 0.2 M)-acetonitrile (1:1, v/v), a flow rate of 1 ml/min and a UV detector set at 240 nm has shown good chromatographic separation for sildenfil and the other related substances. The degree of linearity of the calibration curves, the percent recoveries of sildenafil and related substances, the limit of detection, LOD, and limit of quantitation, LOQ for the HPLC method have been determined. The HPLC method under study was found to be specific, precise, accurate, reproducible indicating stability and robust.

Original language	English
Pages (from-to)	483-492
Number of pages	10
Journal	Journal of Pharmaceutical and Biomedical Analysis
Volume	25
Issue number	3-4
DOIs	https://doi.org/10.1016/S0731-7085(00)00512-4
State	Published - 2001

Keywords

HPLC
Sildenafil
Tablet formulation
Viagra

ASJC Scopus subject areas

Analytical Chemistry
Pharmaceutical Science
Drug Discovery
Spectroscopy
Clinical Biochemistry

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10.1016/S0731-7085(00)00512-4

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title = "Determinaton of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC",

abstract = "This study aimed at developing and validating an HPLC method for the assay of sildenafil citrate and its related substances that might coexist in the drug commercial products and in tablets' formulation as impurities that originate from synthesis processes or degradation. A chromatographic system comprising a μBondapak C18 (10 μm) column, a mobile phase of ammonium acetate (pH 7.0, 0.2 M)-acetonitrile (1:1, v/v), a flow rate of 1 ml/min and a UV detector set at 240 nm has shown good chromatographic separation for sildenfil and the other related substances. The degree of linearity of the calibration curves, the percent recoveries of sildenafil and related substances, the limit of detection, LOD, and limit of quantitation, LOQ for the HPLC method have been determined. The HPLC method under study was found to be specific, precise, accurate, reproducible indicating stability and robust.",

keywords = "HPLC, Sildenafil, Tablet formulation, Viagra",

author = "N. Daraghmeh and M. Al-Omari and Badwan, \{A. A.\} and Jaber, \{A. M.Y.\}",

year = "2001",

doi = "10.1016/S0731-7085(00)00512-4",

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volume = "25",

pages = "483--492",

journal = "Journal of Pharmaceutical and Biomedical Analysis",

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T1 - Determinaton of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC

AU - Daraghmeh, N.

AU - Al-Omari, M.

AU - Badwan, A. A.

AU - Jaber, A. M.Y.

PY - 2001

Y1 - 2001

N2 - This study aimed at developing and validating an HPLC method for the assay of sildenafil citrate and its related substances that might coexist in the drug commercial products and in tablets' formulation as impurities that originate from synthesis processes or degradation. A chromatographic system comprising a μBondapak C18 (10 μm) column, a mobile phase of ammonium acetate (pH 7.0, 0.2 M)-acetonitrile (1:1, v/v), a flow rate of 1 ml/min and a UV detector set at 240 nm has shown good chromatographic separation for sildenfil and the other related substances. The degree of linearity of the calibration curves, the percent recoveries of sildenafil and related substances, the limit of detection, LOD, and limit of quantitation, LOQ for the HPLC method have been determined. The HPLC method under study was found to be specific, precise, accurate, reproducible indicating stability and robust.

AB - This study aimed at developing and validating an HPLC method for the assay of sildenafil citrate and its related substances that might coexist in the drug commercial products and in tablets' formulation as impurities that originate from synthesis processes or degradation. A chromatographic system comprising a μBondapak C18 (10 μm) column, a mobile phase of ammonium acetate (pH 7.0, 0.2 M)-acetonitrile (1:1, v/v), a flow rate of 1 ml/min and a UV detector set at 240 nm has shown good chromatographic separation for sildenfil and the other related substances. The degree of linearity of the calibration curves, the percent recoveries of sildenafil and related substances, the limit of detection, LOD, and limit of quantitation, LOQ for the HPLC method have been determined. The HPLC method under study was found to be specific, precise, accurate, reproducible indicating stability and robust.

KW - HPLC

KW - Sildenafil

KW - Tablet formulation

KW - Viagra

UR - https://www.scopus.com/pages/publications/0034744118

U2 - 10.1016/S0731-7085(00)00512-4

DO - 10.1016/S0731-7085(00)00512-4

M3 - Article

C2 - 11377028

AN - SCOPUS:0034744118

SN - 0731-7085

VL - 25

SP - 483

EP - 492

JO - Journal of Pharmaceutical and Biomedical Analysis

JF - Journal of Pharmaceutical and Biomedical Analysis

IS - 3-4

ER -

Determinaton of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC

Abstract

Keywords

ASJC Scopus subject areas

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