Development and Validation of an HPLC Method Using an Experimental Design for Analysis of Amlodipine Besylate and Enalapril Maleate in a Fixed-dose Combination

Sarisaltik-Yasin, Diren; Bingül, Alev Arslantürk; Karakucuk, Alptug; Teksin, Zeynep S.

doi:10.4274/tjps.galenos.2020.89725

Cited by 13 publications

(4 citation statements)

References 35 publications

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“…The independent variables include buffer ratio, injection volume, ow rate and buffer pH [16][17][18]. Additionally, OFAT analysis was conducted to identify the independent factors that substantially affected the technique outcomes once a working range for each variable was de ned [19,20].…”

Section: Selection Of Critical Independent Variablesmentioning

confidence: 99%

Box-Behnken design-based development of eco-friendly RP-HPLC analytical method for the quantification of erastin from the mesoporous silica nanoparticles

Gupta,

Moorkoth

et al. 2024

Preprint

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The current work aims to optimize, stablish, validate a high-performance liquid chromatography (HPLC) method that possesses sufficient sensitivity and specificity to measure erastin (ERT) in mesoporous silica nanoparticles. The HPLC method was optimized using Design of Experiments (DoE) technique. The Box-Behnken design (BBD) was used and buffer ratio, injection volume, buffer pH, and flow rate were used as the independent factors. The dependent variables were retention time (Rt) of ERT, peak area of ERT, and tailing factor (Tf) of ERT. The optimized chromatographic condition were: buffer ration 80%, buffer pH 3.8 and flow rate 0.9 mL/min, and injection volume 8 µL. The established HPLC method was validated as per ICH Q2 (R1) recommendations. The established method showed the good linearity (R2 = 0.9991) having a range of 12–500 ng/mL and LOD and LOQ was 2.71 ng and 6.25 ng, respectively. The mesoporous silica nanoparticle (MSN) matrix did not affect the specificity of our validated RP-HPLC method of analysis for ERT. Analysing the formulation's surface morphology helped with the confirmation of the synthesized MSNs. The proposed RP-HPLC method was effectively used to calculated the medication loaded in the MSNs as well as to measure the amount of ERT entrapped. The % EE for ERT in MSNs was found to be 76.07% and % DL for ERT in MSNs was found to be 14%, respectively. The established HPLC method was found ecofriendly as per the AGREE analysis.

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Section: Selection Of Critical Independent Variablesmentioning

confidence: 99%

Box-Behnken design-based development of eco-friendly RP-HPLC analytical method for the quantification of erastin from the mesoporous silica nanoparticles

Gupta,

Moorkoth

et al. 2024

Preprint

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“…It works by relaxing blood arteries, allowing blood to flow more freely and allowing the heart to pump blood more efficiently. A review of the literature reveals that several UV, [6][7][8][9][10][11][12][13] HPTLC, [14][15][16] HPLC, 13,16,[17][18][19][20][21][22][23][24][25][26][27] and UPLC 28 techniques have been described for the ADP and ELP alone or in combination with other medicines. To the best of our knowledge, no UHPLC method for determining stability has been published for ADP and ELP combination dose form.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method

Gaikwad,

Bhangale,

Bhandare

2023

Int J. Pharm. Investigation

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Objectives:The key objective of this work is to establish a stability-indicating UHPLC technique for measuring amlodipine and enalapril maleate in bulk and pharmaceutical formulations Materials and Methods: The mobile phase consisted of 0.02M KH 2 PO 4 buffer: Methanol (70:30 v/v). The chromatographic separation was carried out using an Analytical Technologies UHPLC-3000 equipment in conjunction with a variable wavelength programmable UV identifier and a Rheodyne injector equipped with a 5 µL fixed circle. Detection was done at 224 nm with the flow rate of 0.3 mL/min. Results: Amlodipine's retention time was determined to be 0.7 min, while Enalapril's was 1.2 min. The linearity range for Amlodipine and Enalapril was discovered to be 5-25 µg/mL. The technique has been examined in accordance with ICH (International Conference on Harmonisation) standards. A procedure is precise and accurate if the %RSD is less than two. Amlodipine's limit of detection and quantitation ranges are 0.12-0.37 µg/mL and Enalapril's range is 0.10-0.30 µg/mL, respectively. The procedure proved to be simple, linear, swift, exact, accurate, repeatable, and reliable. The drug was prone to acid, basic, and oxidation conditions, according to the stress degradation research. Conclusion: Even in actual samples, the techniques clearly distinguished between the drugs and degradation products. The method was proved as a stability indicating method and can be used in practice for bulk and the dosage forms and also to evaluate the shelf life.

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“…Furthermore, unlike OFAT, which assumes that factors act independently, DOE models can reveal potential interactions between these factors, enhancing the depth of process understanding. The optimization is conducted by employing response surface methodology with desirability function based on different designs such as Box-Behnken design (BBD) and central composite design (CCD) [28][29][30]. The BBD is a secondorder response surface design proposed for optimizing processes and studying the relationship between multiple independent factors and three-level responses.…”

Section: Introductionmentioning

confidence: 99%

“…The BBD requires fewer experimental runs compared to CCD, which makes it less resource-intensive and quicker to implement. It achieves this by omitting extreme factor combinations and focusing on factor settings closer to the center of the design space [30,31]. Many studies have been reported on using BBD to optimize chromatographic conditions [27,29].…”

Section: Introductionmentioning

confidence: 99%

A green liquid chromatographic method using ethanol in mobile phase for the determination of nimesulide and naproxen in gel formulations

YILDIRIM

2023

Turkish Journal of Analytical Chemistry

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Dеtеrmination of nonsteroidal anti-inflammatory drugs (NSAIDs) in pharmacеutical formulations hеlps to еnsurе that thеy arе manufacturеd to thе corrеct spеcifications. Consequently, simple, reliable, and environmentally friendly analytical methods are needed for the quality control of NSAID formulations. In this study, a novel and green liquid chromatographic method was developed for the determination of nimesulide (NIM) and naproxen (NAP) in gel formulations by employing ethanol as a green alternative to hazardous methanol and acetonitrile. The high viscosity of ethanol was compensated by employing a Chromolith HighResolution RP18e monolithic column (100 × 4.6 mm) with low flow resistance. Box-Behnken design with desirability function was employed for the optimization of selected significant parameters: pH (2.8-4), ethanol ratio in the mobile phase (35-55%), and flow rate (0.7-1.5 mL/min). Under optimum conditions, satisfactory separation of analytes was achieved within 5 min. Calibration curves for both analytes were linear between 1-50 μg/mL. Accuracies of intra- and inter-day experiments at low-, middle-, and high-quality control levels ranged from 99.0-101.5% with relative standard deviation values lower than 2.3%. The limits of detection were 0.27 and 0.62 µg/mL for NIM and NAP, respectively. The applicability of the method was demonstrated by analyzing gel formulations. The results of this study indicated that monolithic columns in combination with ethanol as a mobile phase component could be considered a desirable and green alternative for the routine analysis of NSAIDs in quality control laboratories.

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Development and Validation of an HPLC Method Using an Experimental Design for Analysis of Amlodipine Besylate and Enalapril Maleate in a Fixed-dose Combination

Cited by 13 publications

References 35 publications

Box-Behnken design-based development of eco-friendly RP-HPLC analytical method for the quantification of erastin from the mesoporous silica nanoparticles

Box-Behnken design-based development of eco-friendly RP-HPLC analytical method for the quantification of erastin from the mesoporous silica nanoparticles

Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method

A green liquid chromatographic method using ethanol in mobile phase for the determination of nimesulide and naproxen in gel formulations

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