Development of stability indicating HPTLC method for estimation of antihypertensive drug combination nifedipine and valsartan

Abstract

A precise and accurate method for the analysis of antihypertensive drug combination nifedipine and valsartan was developed using the HPTLC method. The stationary phase used was a precoated silica gel G60-F 254 aluminium sheet and the mobile phase was acetonitrile: methanol: n-butanol: acetic acid (6:2:2:0.1, v/v/v/v). The detection of spots was carried out densitometrically using a UV detector at 230 nm in the absorbance mode. The Rf values of valsartan and nifedipine were found to be 0.25 and 0.65, respectively. The calibration curve was found to be linear in the range of 120-320 ng/band and 900-2400 ng/band for nifedipine and valsartan, respectively. Forced degradation studies were performed using stress conditions like acid and base hydrolysis, photolytic, thermal and oxidative stress degradation to develop the stability indicating method. The degradation study indicated that nifedipine was susceptible to acid-base hydrolysis, oxidative stress degradation and photolytic degradation, while valsartan was susceptible to acid-base hydrolysis and oxidative stress degradation.

LC–MS/MS bioanalytical method for the quantitative analysis of nifedipine, bisoprolol, and captopril in human plasma: Application to pharmacokinetic studies

“…From the literature survey, various approaches have been reported for the estimation of NIF, CAP and BIS alone or in combination with other drugs. The reported methods include HPLC (Ahmed et al, 2018; Andal et al, 2022; Bahgat et al, 2022; Kondratova et al, 2017; Rashid et al, 2022; Rastkari et al, 2013; Sultan et al, 2013; Sultana et al, 2011; Tatar Ulu & Aydoğmuş, 2012), LC–MS/MS (Giebułtowicz et al, 2015; Grigoriev et al, 2016; Logoyda, 2020; Logoyda et al, 2020; Logoyda et al, 2021; Todevska et al, 2022; Tonooka‐Kubota et al, 2022; Tutunji et al, 2009; Zhao et al, 2023), HPTLC (Aayushi & Shah, 2022; Chitlange et al, 2009; Kakde et al, 2008; Shah et al, 2019), spectrofluorimetric (Abd Elhaleem et al, 2022; Abdelwahab et al, 2018; Attia et al, 2023; Derayea et al, 2022; Dewangan et al, 2022; Dong et al, 2022; Han et al, 2022; Khan et al, 2014; Roshdy et al, 2023; Sheng et al, 2022; Wang et al, 2022; Wu et al, 2022; Xi et al, 2022), UV spectrophotometric (Abed, 2020; Gouda & Amin, 2010; Gudruman et al, 2012; Hamad et al, 2023; Mishra, 2022; Tulasamma & Venkateswarlu, 2016; Ulu & Kel, 2012) and electrochemical methods (Al‐Farhan et al, 2023; Frag et al, 2019; Górska et al, 2022; Hassan et al, 2022; Karimi‐Maleh et al, 2017; Khairy et al, 2017; Koçak & İpek, 2022; Mokhtari et al, 2018; Mourad et al, 2020; Pourhakkak et al, 2022; Soomro et al, 2017; Zare et al, …”