Simultaneous UPLC Estimation of Fexofenadine HCl and Montelukast Sodium Tablets

Mustafa, Mohamed Ahmed; Amuthalakshmi, S.; Nalini, C. N.

doi:10.5958/0974-360x.2017.00111.1

Cited by 5 publications

(1 citation statement)

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“…The degradation byproducts were effectively separated from the primary compound. Mustafa M. et al [51] introduced a rapid, simple, and sensitive gradient ultra-performance liquid chromatographic (UPLC) technique for determining fexofenadine HCl and montelukast sodium. The operation employed a Thermo Scientific UPLC system and a Waters (symmetrical) C18 column (1.8 microns, 4.6 x 50 mm).…”

Section: Ultra High Performance Liquid Chromatography (Uhplc)mentioning

confidence: 99%

An In-Depth Survey of Analytical Techniques for Quantifying Antihistamines and Antiasthmatics in Diverse Dosage Forms.

2023

Journal of Chemical Health Risks

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This article presents a comprehensive examination of various analytical methodologies employed in the quantification of antihistamines and antiasthmatics, specifically desloratadine, levocetirizine hydrochloride, fexofenadine hydrochloride, and montelukast sodium, in both dosage forms and biological matrices. The analytical techniques encompass electrometric methods, UV spectroscopy, mass spectroscopy, thin-layer chromatography, high-performance liquid chromatography (HPLC), and high-performance thin-layer chromatography (HPTLC). The investigation systematically addresses the essential analytical validation parameters applicable to each methodology. The study reveals that HPLC and UV-Vis spectrophotometry emerged as the predominantly utilized analytical techniques by the researchers.

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Section: Ultra High Performance Liquid Chromatography (Uhplc)mentioning

confidence: 99%

An In-Depth Survey of Analytical Techniques for Quantifying Antihistamines and Antiasthmatics in Diverse Dosage Forms.

2023

Journal of Chemical Health Risks

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Green micellar UPLC and complementary eco-friendly spectroscopic techniques for simultaneous analysis of anti-COVID drugs: a comprehensive evaluation of greenness, blueness, and whiteness

katamesh,

Abbas,

Halim

et al. 2024

BMC Chemistry

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The development of sustainable analytical methodologies that minimize hazards, waste generation, and energy consumption has become crucial. This study introduces pioneering green‒blue-white approaches for the simultaneous quantification of montelukast sodium (MLK) and fexofenadine hydrochloride (FEX) in combination formulations. The first approach employs an ultra-performance liquid chromatographic method (UPLC) with a green micellar mobile phase of 0.02 M sodium dodecyl sulfate and 10% 1-pentanol (65:35%). The method demonstrated excellent resolution, peak symmetry, and a short analysis time, with retention times of 3.53 min for MLK and 1.67 min for FEX. The MLK and FEX linearities were 1–260 and 1.2–312 μg/mL, respectively. The second approach involves complementary built-in spectroscopic techniques (second derivative, third derivative, and ratio difference methods) using water as a solvent, providing a green, simple, low-cost alternative in laboratories where expensive chromatographic devices may not be readily available. The MLK and FEX linearities were 3–50 and 3–60 μg/mL, respectively. All methods were comprehensively validated and showed satisfactory results. The proposed methods demonstrated excellent linearity (r2 ≥ 0.9990), accuracy (recovery 98.5–101.5%), and precision (RSD ≤ 2%) across wide concentration ranges. A multifaceted evaluation was conducted to assess the environmental sustainability, real-world applicability, and economic viability of the proposed methods in comparison with previously reported techniques. This comprehensive assessment leveraged several state-of-the-art tools, including NEMI, ComplexGAPI, AGREE, ESA, BAGI, and RGB12. The suggested approaches exhibited favorable quadrant profiles in the NEMI and ComplexGAPI assessments, coupled with higher AGREE scores (0.90, 0.86) than reported (0.62, 0.74, 0.75, 0.69, 0.74, 0.74, and 0.75), in addition to higher ESA score (88, 92) than reported (75, 84, 85, 79, 82, 82, and 83), collectively affirming their environmentally friendly credentials. Moreover, we embraced the innovative notions of 'blueness' and 'whiteness' assessment by harnessing the recently formulated BAGI and RGB12 algorithms. The higher BAGI score (90, 82.5) than reported (72.5, 70, 70, 67.5, 67.5, 67.5, and 72.5), confirmed the excellent real-world applicability of the proposed methods, while the notable RGB12 indices (89.8, 88.1) than reported (67.8, 72.8, 71.5, 67.1, 73.7, 70.3, and 73.2), validated their cost-effectiveness and overall sustainability, contributing to an eco-friendly future for quality control processes.

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Development and validation of a stability indicating UPLC method for determination of Darolutamide in its tablet formulation

Venkatesh

Kulandaivelu

Rao

et al. 2022

RJPT

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Darolutamide is an orally active, second generation non-steroidal anti-androgen. The objective of this study was to develop a simple and fast stability indicating method for the determination of Darolutamide in bulk and tablets. Darolutamide was eluted on a Zorbax SB-C18 column (100X2.1mmX1.8µ) with a mobile phase of 8mM ammonium acetate, pH: 5.4: acetonitrile (66:34 v / v) in isocratic mode at a flow rate of 0.4 ml / min. The analyte was quantified using a 272 nm PDA detector. The chromatograms of darolutamide obtained with this method showed a well resolved retention time at 0.83 min of its excipients and degradation products. The area of the peak with respect to the concentration calibration curves, which were linear from 70 to 210 µg / ml, had a regression coefficient (r2) greater than 0.999. The detection limit (LOD) and the limit of quantification (LOQ) were found at 1.80 and 6.01 µg/mL respectively. Accuracy and precision have been determined and perfectly matched to the ICH standards. The study showed that the proposed UPLC method was simple, fast, robust and reproducible, which can be used for the evaluation of the purity and stability of the drug without interference from excipients or decomposition products of active pharmaceutical ingredients.

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Simultaneous UPLC Estimation of Fexofenadine HCl and Montelukast Sodium Tablets

Cited by 5 publications

References 0 publications

An In-Depth Survey of Analytical Techniques for Quantifying Antihistamines and Antiasthmatics in Diverse Dosage Forms.

An In-Depth Survey of Analytical Techniques for Quantifying Antihistamines and Antiasthmatics in Diverse Dosage Forms.

Green micellar UPLC and complementary eco-friendly spectroscopic techniques for simultaneous analysis of anti-COVID drugs: a comprehensive evaluation of greenness, blueness, and whiteness

Development and validation of a stability indicating UPLC method for determination of Darolutamide in its tablet formulation

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