Development and Validation of RP-HPLC Method for Estimation of Amlodipine Besylate and Celecoxib in Pharmaceutical Formulation

Abstract

A simple, precise, accurate, and rapid reverse phase-high performance liquid chromatography (RP-HPLC) method with UV-Visible detector has been developed and subsequently validated for the simultaneous determination of amlodipine besylate(AML) and celecoxib(CEL) in their combined tablet dosage form. The separation was based on the use of a Flowrosil C18 analytical column (250 × 4.6 mm, i.d., 5 µm). The mobile phase consisted of a mixture of 80 volumes of acetonitrile and 20 volumes of water. The chromatography was performed by isocratic elution at a flow rate of 1 mL/min. Analytes were detected at 250 nm, with linear calibration curves at concentration ranges of 2-12 µg/ml and 50-300 µg/ml for AML and CEL respectively. The retention time of AML and CEL were 1.98 and 3.15 min respectively. The recoveries obtained were 99.46‒101.36% for AML, 99.57‒101.42% and 99.96–100.87 % for CEL. The method was validated according to International conference of harmonisation guidelines in terms of accuracy, precision, specificity, robustness, limits of detection and quantitation, and other aspects of analytical validation. The developed method was applied successfully for HPLC analysis of commercial pharmaceutical products including AML and CEL.
 Keywords: Amlodipine besylate; Celecoxib; RP-HPLC.

A Review on Simultaneous Determination of Anti-Hypertensive Drug Combinations Containing Amlodipine Besylate using Chromatographic Analysis

“…The recoveries were acceptable with the ranges, Amlodipine besylate between 99.46-101.36% and Celecoxib between 99.57-101.42%. The ICH guideline based method showed needed specificity, robustness, limits of detection and quantitation [41] .…”

Utilization of erythrosine B in spectrofluorimetric quenching analysis of amlodipine and perindopril in pharmaceutical and biological matrices

“…Amlodipine (AML), is a dihydropyridine compound with antihypertensive and antianginal effects with the nomenclature of 3‐ O ‐ethyl 5‐ O ‐methyl 2‐(2‐aminoethoxymethyl)‐4‐(2‐chlorophenyl)‐6‐methyl‐1,4‐dihydropyridine‐3,5‐dicarboxylate (Figure 1a). Various analytical techniques for determining AML, either alone or in combination with other drugs, have been published including spectrophotometry [1–8], spectrofluorimetry [9–28], and electrochemical [6, 29] and chromatographic approaches such as TLC [30], LC–MS/MS [31] and HPLC [4, 5, 32–42]. Perindopril (PER) is an antihypertensive nonsulfhydryl angiotensin‐converting enzyme (ACE) inhibitor that is used to treat hypertension and stable coronary artery disease with the nomenclature of (2 S ,3 aS ,7 aS )‐1‐[(2 S )‐2‐[[(2 S )‐1‐ethoxy‐1‐oxopentan‐2‐yl]amino]propanoyl]‐2,3,3 a ,4,5,6,7,7 a ‐octahydroindole‐2‐carboxylic acid (Figure 1b).…”

“…spectrofluorimetry [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28], and electrochemical [6,29] and chromatographic approaches such as TLC [30], LC-MS/MS [31] and HPLC [4,5,[32][33][34][35][36][37][38][39][40][41][42].…”

Spectrofluorimetric assay of amlodipine and perindopril in their raw materials, pharmaceutical formulations and spiked human plasma through the formation of complexes with Eosin Y

“…1-a). Various analytical techniques have been reported for determination of AML, either alone or in combination with other drugs, including, spectrophotometric techniques (Attimarad et al 2019;Erden et al 2016;Hegazy et al 2015;Karadurmuş et al 2018;Khachornsakkul and Dungchai 2020;Mahant et al 2016;Saad et al 2016;Siridevi et al 2019), spectrofluorimetric techniques (Attala et al 2020;Dinç et al 2017;El-Kosasy et al 2015;Ibrahim et al 2015;Mabrouk et al 2018;Mohamed et al 2016;Mohammed 2015;Nasr and Shalan 2020;Sh Shalan et al 2015;Shereen Shalan and Nasr 2019), electrochemical techniques (Erden et al 2016;Wei et al 2016) and chromatographic techniques such as TLC-densitometry (Patel et al 2020a, b), LC-MS/ MS (Rezk and Badr 2020) and HPLC (Alaama et al 2015;Attimarad et al 2020;Desai et al 2019;Duraisamy and Jaganathan 2017;Ebeid et al 2015;Karadurmuş et al 2018;Mahant et al 2016;Nagamani et al 2020;Naik et al 2020;Patel et al Patel et al 2020a, b;Saleh et al 2020;Saputri et al 2018). Perindopril (PER), is an antihypertensive nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor used to treat hypertension and stable coronary artery disease with nomenclature of (2S,3aS,7aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acid (Fig.…”