OCT 2014 ARTICLE LIST >>
PharmaTutor (October- 2014)
ISSN: 2347 - 7881
(Volume 2, Issue 10)
Received On: 04/08/2014; Accepted On: 13/08/2014; Published On: 01/10/2014
AUTHORS: Chetan A. Prajapati*, Bhavik S. Patel, R.Badmanaban
Department of Quality Assurance, Shri Sarvajanik Pharmacy College,
Mehsana, Gujarat, India
*prajapatichetan25@gmail.com
ABSTRACT:
A novel, precise, accurate and economic high-performance thin-layer chromatographic (HPTLC) method was developed, optimized and validated for simultaneous determination of Sildenafil Citrate and Dapoxetine Hydrochloride. The chromatographic separation was performed on precoated silica gel 60 GF254 plate with hexane: methanol: diethyl amine 9.2:1.6:1.2 (v/v/v) as mobile phase. The plate was developed to distance of 8.0 cm at ambient temperature. The developed plate was scanned and quantified at their single selected wavelength of 241 nm for Sildenafil Citrate and Dapoxetine Hydrochloride. Experimental conditions such as band size, chamber saturation time, migration time of solvent front, etc. were critically studied and the optimum condition were selected. The drugs were satisfactorily resolved with RF 0.21 ± 0.02 for Sildenafil Citrate and 0.72 ± 0.02 for Dapoxetine Hydrochloride. The method was validated for linearity, accuracy, precision, and specificity. The calibration plot was linear between 2000–12000 ng per spot for Sildenafil Citrate and 1200–7200 ng per spot for Dapoxetine Hydrochloride. The limits of detection for Sildenafil Citrate and Dapoxetine Hydrochloride were 210 and 75ng per spot respectively and limit of quantification for Sildenafil Citrate and Dapoxetine Hydrochloride were 450 and 240ng per spot respectively. It is a user-friendly and important tool for analysis of combined fixed dosage forms. Methods were validated statistically and recovery studies were carried out. The method herein described can be employed for quality control and routine analysis of drugs inpharmaceutical formulations.
How to cite this article: CA Prajapati, BS Patel, R Badmanaban; Development and Validation of HPTLC Method for Simultaneous Estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in Combined Dosage Form; PharmaTutor; 2014; 2(10); 142-152
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