Comparative study of spectrophotometric and spectrodensitometric techniques for the estimation of riociguat in tablets
- PDF / 1,161,307 Bytes
- 10 Pages / 595.276 x 790.866 pts Page_size
- 29 Downloads / 141 Views
IGINAL RESEARCH PAPER
Comparative study of spectrophotometric and spectrodensitometric techniques for the estimation of riociguat in tablets Twinkle N. Patel 1 & Praful P. Dedhiya 1
&
Hitika B. Patel 1 & Shailesh A. Shah 1
Received: 10 June 2020 / Accepted: 11 August 2020 # Akadémiai Kiadó, Budapest, Hungary 2020
Abstract The present research paper includes the development, validation, and comparison of three analytical methods including spectrofluorimetric, ultraviolet (UV)-spectrophotometric, and spectrodensitometric methods based on high-performance thinlayer chromatographic (HPTLC) technique for the estimation of riociguat in tablet dosage form. The estimation was performed at wavelength maxima of 322 nm for UV-spectrophotometry, and for spectrofluorimetric method, excitation wavelength was 300 nm and emission wavelength was 465 nm. Quantification by HPTLC method was carried out at wavelength maxima of 323 nm using aluminum-backed pre-coated silica gel 60 F254 as the stationary phase and ethyl acetate–methanol–glacial acetic acid (8:2:0.3, v/v) as the mobile phase. The methods were validated according to the International Council for Harmonization (ICH) Q2(R1) guideline, where the limits of detection and quantification were found to be 0.240 and 0.728 μg/mL, 0.193 and 0.586 μg/mL, and 3.35 and 10.15 ng/band for spectrofluorimetric, UV-spectrophotometric, and HPTLC method, respectively. The developed methods were successfully applied for quantification of the content of active ingredient and content uniformity. Statistical comparison was done by ANOVA and paired t test showing no significant difference between the three methods. The proposed methods were successfully applied for content uniformity test of riociguat in its tablet dosage form. Keywords Spectrofluorimetry . UV-spectrophotometry . High-performance thin-layer chromatography . Comparative study . Riociguat . Validation
1 Introduction Riociguat is chemically methyl N-(4,6-diamino-2-{1-[(2fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3yl}pyrimidin-5-yl)-N-methylcarbamate (Fig. 1) [1]. It is a soluble guanylate cyclase (sGC) agonist used in the treatment of chronic thromboembolic pulmonary hypertension. It sensitizes sGC to endogenous NO, and it directly stimulates sGC receptors independent of NO availability, resulting in vasorelaxation and antiproliferative effects [2–5]. There are many analytical methods available for estimation of a drug in its pharmaceutical dosage form. Comparison of these analytical methods is important for choosing a sensitive, accurate, and economical method for the analysis of a particular drug in pharmaceutical dosage form [6–11]. An extensive * Praful P. Dedhiya [email protected] 1
Maliba Pharmacy College, Uka Tarsadia University, Maliba Campus, Gopal Vidyanagar, Bardoli, Gujarat 394350, India
literature survey reveals one UV-visible spectroscopy [12–14] and few liquid chromatographic methods for the estimation of riociguat in pharmaceutical dosage form [15–19], but no method has been reported for the estimation
Data Loading...
