Development of Analstical Determination of Sildenafil Citrate Tablet

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Kanokwan Jarukamjorn
Jomjai Pcerapattana
Sukanya Pattarajinda

Abstract


Sildenafil citrate is a selective PDE5 inhibitor which is widely used for erectile dysfunction at present. Consequently, the analytical method of sildenafil citrate is not available in the latest version of Pharmacopoeia. A couple of analytical methods of sidenafil citrate by UV and HPLC techniques were developed and validated. Methanol (10%) was an appropriate solvent for extraction of sildenafil citrate from pharmaceutical excipients for both techniques. The UV method with lmax at 292 nm showed linearity from 5-100 p.g/ml with within-day and between-day precision less than 0.46 and 3.87 %, respectively, accuracy as % recovery 101.16+3.23 %, LOD and LOQ at 100 and 340 ng/ml, respectively. The HPLC system was consisted of C18 column with a flow rate of mixture of acetonitrile and 0.1 M sodium acetate buffer pH 7.0 (70:30) at flow rate of 1.0 ml/m in as the mobile phase. lmax was set at 292 nm. The HPLC validation parameters were clearly expressed in linearity range 5-100 mg/ml with within-day and between-day precision less than 1.58 and 2.09 %, respectively, accuracy as % recovery 98.86+1.35 %, LOD and LOQ at 40 and 75 ng/ml, respectively.


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Pharmacy

References

Altiokka G, Alkosar Z, Sener E and Tuncel M. (2001). FIA of sildenafil citrate using UV-detection. J Pharm Biomed Anal, 25, pp. 273-275.
Boulanger B, Chiap P, Dewe W, Crommen J and Hubert PH. (2003). An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: Progresses and limitations. J Pharm Biomed Anal, 32, pp. 753-765.
Causon R. (1997). Validation of chromatographic methods in biomedical analysis: Viewpoint and discussion. J Chromatogr B, 689, pp. 175-180.
Daraghmeh N, Al-Omari M, Banwan AA and Jaber AMY. (2001). Determination of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC. J Pharm Biomed Anal, 25, pp. 483-492.
Dinesh ND, Nagaraja P, Made GNM and Rangappaet KS. (2002). Extractive spectrophotometric methods for the assay of sildenafil citrate (Viagra®) in pure form and in pharmaceutical formulations. Taianta, 57, pp. 757-764.
Dinesh ND, Vishukumar BK, Nagaraja P, Madegowda NM and Rangappa KS. (2002). Stability indicating RP-LC determination of sildenafil citrate (Viagra®) in pure form and in pharmaceutical sample. J Pharm Biomed Anal, 29, pp. 743-748.
ICH Guideline: Validation of analytical procedures. 1996, Retrieved August 25, 2005, from http:/ /www.ich.org/cache/compo/276-254-1 .html.
Jeong CK, Lee HY, Jang MS, Kim WB and Lee HS. (2001). Narrowbore high-performance liquid chromatography for simultaneouse determination of sildenafd and metabolite UK-103,320 in human plasma using column switching. J Chromatogr B, 752, pp. 141-147.
Langtry D and Markham A. (1999). Sildenafil: A review of its used in erectile dysfunction. Drugs, 57, pp. 967-989.