Simultaneous Determination of Amlodipine and Aliskren in Tablets by High-Performance Liquid Chromatography

Abstract

A new, simple, rapid and specific reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for the simultaneous determination of amlodipine besylate and aliskiren hemifumarate. The HPLC separation was achieved on an RP-18 column (250 × 4.6 mm) using a mobile phase of triethylamine-orthophosphoric acid buffer (50 mM, pH 3.0), acetonitrile and methanol (50:40:10, v/v/v) at a flow rate of 1 mL/min. The method was validated for specificity, linearity, precision, accuracy and robustness. The degree of linearity of the calibration curves, the percent recovery values of amlodipine and aliskiren and the limits of detection (LOD) and quantification (LOQ) for the HPLC method were determined. The linearity of the method was found to be in the concentration range of 5.0-50.0 µg/mL for aliskiren hemifumarate and 2.65-26.50 µg/mL for amlodipine besylate, LOD and LOQ values were 0.51, 0.95, 1.70 and 3.18 µg/mL for amlodipine besylate and aliskiren hemifumarate. The proposed method was successfully applied to amlodipine besylate and aliskiren hemifumarate in pharmaceutical dosage mixtures without any interference from the excipients. The method was found to be precise, accurate, reproducible and robust. The results agreed with those obtained using the developed reference method.

Application of supercritical fluid chromatography for separation and quantitation of 15 co‐formulated binary anti‐hypertensive medications using a single elution protocol

“…The results obtained showed acceptable accuracy and precision of the assay, with no interference from the excipients present in the formulations. Further, Student's t ‐test and F ‐test were applied (at 95% confidence level) for the statistical comparison between the results obtained by applying the proposed SFC method for the binary combinations and reported methods (Bharathi, Hotha, Chatki, Satyanarayana, & Venkateswarlu, 2012; de Diego, Soto, & Mennickent, 2014; Deshmukh, Deo, Inam, & Lambat, 2018; Elgorashe, Idris, Abdelrahman, & Saeed, 2013; Gao et al, 2010; Kamble, Mahadik, Khatal, & Dhaneshwar, 2010; Karra, Pilli, Inamadugu, & Seshagiri Rao, 2012; Karvelis, Kalogria, & Panderi, 2014; Kolocouri, Dotsikas, Apostolou, Kousoulos, & Loukas, 2007; Özdemir & Akyüz, 2014; Rane, Sangshetti, & Shinde, 2008; Ravi, Inamadugu, Pilli, Sreenivasulu, & Ponneri, 2012; Shah, Parekh, et al, 2017; Srikanth, Murali, Vekaria, Rao, & Mantena, 2015; Tian, Tian, Tian, Wang, & Mo, 2008). The values found for both the test were less than the tabulated values, suggesting insignificant differences between the methods in terms of accuracy and precision (Table 5).…”

“…Özdemir and Akyüz (2014) (combination 5), Bharathi, Hotha, Chatki, Satyanarayana, and Venkateswarlu (2012) (combination 6), Kolocouri, Dotsikas, Apostolou, Kousoulos, and Loukas (2007) (for combination 7), Srikanth et al (2015) (combination 8), Rane, Sangshetti, and Shinde (2008) (for combination 9), Tian, Tian, Tian, Wang, and Mo (2008) (for combination 10), Elgorashe, Idris, Abdelrahman, and Saeed (2013) (for combination 11),…”

“…Several methods are available in literature for the separation and quantitation of these co‐formulated binary anti‐hypertensive medications. These methods include spectrophotometry (Erk, 2003; Garg, Saraf, & Saraf, 2008; Lakshmi & Lakshmi, 2010; Lakshmi & Lakshmi, 2011; Maggio, Castellano, & Kaufman, 2008; Vignaduzzo, Maggio, Castellano, & Kaufman, 2006), spectrofluorometry (Belal, Mahrous, Abdel‐Khalek, Daabees, & Khamis, 2014; Derayea, El‐din, & Mohammed, 2018; Dinç, Ertekin, & Büker, 2017; Ebeid, Elkady, El‐Zaher, El‐Bagary, & Patonay, 2014; El‐Kosasy, Tawakkol, Ayad, & Sheta, 2015; Shaalan & Belal, 2010), capillary electrophoresis (Alnajjar, 2011; Alnajjar, Idris, Attimarad, Aldughaish, & Elgorashe, 2013; Sangoi, Wrasse‐Sangoi, Oliveira, et al, 2011), infrared spectroscopy (Casian et al, 2017; Vranic & Vandamme, 2015), Raman spectroscopy (Casian et al, 2017), sequential injection chromatography (Elgorashe, Idris, Abdelrahman, & Saeed, 2013), high‐performance thin layer chromatography (Deshmukh, Deo, Inam, & Lambat, 2018; Kamble, Mahadik, Khatal, & Dhaneshwar, 2010; Pandya et al, 2017; Shah, Suhagia, Shah, & Patel, 2009), HPLC‐UV/DAD (diode array detector) (Almeida, Fernandes, Pianetti, & César, 2018; Brondi, Garcia, & Trevisan, 2017; Burnier, Vuignier, & Wuerzner, 2014; de Diego, Soto, & Mennickent, 2014; de Diego et al, 2018; Dinç, Ertekin, & Büker, 2017; Karvelis, Kalogria, & Panderi, 2014; Kurbanoglu, Gumustas, & Ozkan, 2013; Li, Lai, Xuan, Gao, & Li, 2016; Mannemala & Nagarajan, 2015; Özdemir & Akyüz, 2014; Rane, Sangshetti, & Shinde, 2008; Sangoi, Wrasse‐Sangoi, de Oliveira, et al, 2011; Tian, Tian, Tian, Wang, & Mo, 2008), ultra‐performance liquid chromatography (UPLC)‐DAD (Almeida, Fernandes, Pianetti, & César, 2018; Dinç & Ertekin, 2016; Srikanth, Murali, Vekaria, Rao, & Mantena, 2015), LC–MS/MS (Bharathi, Hotha, Chatki, Satyanarayana, & Venkateswarlu, 2012; Gao et ...…”

Simultaneous analysis of aliskiren and hydrochlorothiazide in pharmaceutical preparations and spiked human plasma by HPTLC

“…Several methods have been reported for the determination of ALS as an isolated sample or together with other antihypertensive drugs in more complicated matrices such as pharmaceutical formulations and biological fluids. These methods have been based on spectrophotometry [6][7][8], spectrofluorometry [9,10], electrophoresis [11,12], liquid chromatography (LC) [8,[13][14][15][16][17][18][19][20][21], LC-MS/MS [22][23][24][25] and UPLC-MS/MS [26]. Similarly, a number of analytical methods have been presented for the estimation of HCTZ as a single analyte [27] and in the presence of different antihypertensive agents [8,12,14,16,18,19,[28][29][30][31][32][33][34][35][36][37][38][39] in pharmaceutical preparations and biological matrices using spectrophotometry [29,32], capillary electrophoresis [28], HPTLC [30,…”