You are here

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF SILDENAFIL CITRATE AND DAPOXETINE HYDROCHLORIDE IN THEIR COMBINED TABLET DOSAGE FORM

Journal Name:

Publication Year:

Abstract (2. Language): 
The present manuscript describes new, simple, accurate, and precise high performance thin layer chromatography method for the simultaneous determination of Sildenafil Citrate and Dapoxetine Hydrochloride in combined tablet dosage form. Chromatographic separation of the drugs was performed on aluminium plates are coated with silica gel 60 F254 as the stationary phase and the solvent system consisted of Chloroform: Methanol: Acetonitrile : Glacial acetic acid (5:1:2.5:1.5 v/v). Densitometric evaluation of the separated zones was performed at 292 nm. The two drugs were satisfactorily resolved with Rf values 0.82 and 0.56 for Sildenafil Citrate and Dapoxetine Hydrochloride respectively. The linear regression data for the calibration plots showed good relationship with r2 = 0.993 from 500-1500 ng/spot for Sildenafil Citrate and r2 = 0.995 from 1000-3000 ng/spot for Dapoxetine Hydrochloride. The methods were validated for precision, accuracy, and recovery. The percentage recovery for Slidenafil Citrate was found to be 100.02% – 100.08% and 99.95% – 99.99%.Dapoxetine Hydrochloride. The limits of detection and quantification were 143.3625 and 434.4318 ng/spot per spot for Sildenafil Citrate and 315.4586 and 955.9351 ng/spot per spot Dapoxetine Hydrochloride, respectively.

REFERENCES

References: 

1. Amar MB and Nesrine TL: Stability
Indicating Methods for the Determination
of Sildenafil Citrate In The Presence Of Its
Degradation Product. International Journal
of Comprehensive Pharmacy. 2011: 2(07);
1-6.
2. “Drug bank: Sildenafil citrate”,
November 2011
http://www.drugbank.ca/drugs/DB00203
3.Martin Dale, Pharmaceutical press, 2005,
34th edition, pp 1744-45.4.The Merck Index, Merck Research
Laboratories, USA, 14th edition,
pp1466,476
5.Ashok K, Gaurav R, Gaurav S and Atul
S: To Develop Uv Spectrophotometric
Method For The Estimation Of Sildenafil
Citrate In Bulk And Tablet. IJPRD. 2010;
2(7): 12.
6.Harikrishna K, Nagaralli BS and
Seetharamappa J: Extractive
Spectrophotometric Determination of
Sildenafil Citrate. Pharmaceutical
Formulations Journal of Food and Drug
Analysis. 2008; 16(1): 11-17.
7.Shri Krishna B, Baokar, BS, Sivanand V
and Prathees GK: Analytical method
development and validation for estimation
of sildenafil citrate from tablet dosage
form by using RP-HPLC. Al. Int. J. Res.
Pharm. Sci. 2011; 2(2): 130-136.
8.Prasanna Kumar R and Ramanjaneya Y:
Validation and Stability Indicating RPHPLC
Method for the Determination of
Sildenafil Citrate Pharmaceutical
Formulations and Human Plasma. EJournal
of Chemistry journals. 2008;
5(S2): 1117-1122.
9.Kannappan N, Deepthi Yada, Divya
Yada, Shashikanth and Mannavalan. R:
Method Development and Validation of
Stability Indicating Methods for Assay of
Tadalafil and Sildenafil Citrate by HPLC.
International Journal of Chem Tech
Research. 2010; 2(1): 329-333.
10. Srikanth Reddy, Usha k, Vishal Awari
and Meyyanathan S: India Bio analytical
method for the determination of Sildenafil
citrate in human plasma by HPLC.
Scintificipca.org,
2011/09/15/201109151417360A.rtf.
11. Michael Kidane Tesfu, Thesis:
Development and Validation of Bio
analytical Assay Methods for Sildenafil in
Human Plasma. University of the Free
State, 2004.
12. Ehab AA, Maged SA and Abdel H:
HPTLC Determination of Sildenafil in
Pharmaceutical Products and Aphrodisiac
Herbal Preparations. 2005; (18): 372-376.
13. Drug Bank: “Dapoxetine
hydrochloride”, November 2011
www.drugbank.ca/drugs/DB00539.
14. Kiran Kumar D, Nataraj KS, Kesinath
Reddy and Suresh Kumar: Method
Development and Validation for Analysis
of Dapoxetine in Bulk and Pharmaceutical
Dosage Form by RP-HPLC. International
Journal of Chem Tech Research. 2010;
205-211.15. ICH Harmonized Tripartile Guideline.
Validation of Analytical Procedures: Text
and Methodology Q2 (R2), International
Conference on Harmonization, Geneva,
Switzerland Nov. 2005.

Thank you for copying data from http://www.arastirmax.com