Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for Simultaneous Estimation of Fexofenadine Hydrochloride, Montelukast Sodium and Ambroxol Hydrochloride in Tablet Dosage Form

Sharma, Kamna; Bhatia, Rohit; Anghore, Durgadas; Singh, Virender; Khare, Rajshree; Rawal, Ravindra K.

doi:10.1080/22297928.2018.1465470

Cited by 8 publications

(6 citation statements)

References 15 publications

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“…These drugs obeyed the Beer–Lambert's law in the concentration range of 6–26, 4–24, and 8—28 μg/mL in both UV methods, showing a correlation coefficient of r 2 = 0.999. The RP‐HPLC and UV methods showed good reproducibility and recovery with the percentage RSD less than 5% [51] (Table 4).…”

Section: Analytical Methods Used To Estimate Montelukast Sodiummentioning

confidence: 99%

An analytical review for the estimation of montelukast sodium

Anant

Saha

Dhiman

et al. 2022

Separation Science Plus

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Montelukast is a highly potent and selective receptor antagonist of cysteinyl leukotrienes (CysLT1) used in chronic asthma and vasoconstriction reduction and also used in allergies, swelling, hay fever, and shortness of breath. For the measurement of montelukast sodium in biological and pharmaceutical samples, there are different asynchronous and concurrent analytical methods, such as high‐performance thin layer chromatography, UV spectroscopy, capillary electrophoresis, high‐performance liquid chromatography, and liquid chromatography‐mass spectrometry, have been developed. The pathogenesis of asthma, mechanism of action, and various analytical methods for the detection of montelukast sodium and its combination of dosage forms and biological samples have been described in the present review. Ranjan et al. suggested the reverse phase high‐performance liquid chromatography approach for estimating montelukast in rabbit plasma and found the best limit of detection result of 1.0 ng/mL. Ezzeldin et al. developed a liquid chromatography with tandem mass spectrometry system for the simultaneous detection of combinations of montelukast, gliclazide, and nifedipine. The authors conclude that the studies described in the present manuscript will assist researchers in choosing a simple, rapid, and responsive method for the analysis of montelukast sodium and its combinations.

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Section: Analytical Methods Used To Estimate Montelukast Sodiummentioning

confidence: 99%

An analytical review for the estimation of montelukast sodium

Anant

Saha

Dhiman

et al. 2022

Separation Science Plus

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“…The recent U.S. Food and Drug Administration (FDA) method validation guidance documents [20][21][22] as well as the United States pharmacopoeia (USP) both refer to ICH guidelines [23]. Validation is a very important factor in controlling the reliability of the method that is determined by the validation results, where accuracy, sensitivity, applicability, specificity, the limit of detection, and the limit of quantification are reported [24,25]. Validated analytical methods play a key role in achieving the quality and safety of the final product, especially in the pharmaceutical industry.…”

Section: Analytical Methods Validationmentioning

confidence: 99%

A Validated Method Developed for Estimation of Lifitegrast in Bulk and Pharmaceutical Dosage Form by UV-Spectrophotometer and RP-HPLC

Pannu¹,

Bhatia²,

Kumar³

2022

austinjanalpharmchem

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Lifitegrast is an LFA-1 antagonist, tetrahydroisoquinoline derivative, formulated as sterile eyedrops. Lifitegrast ophthalmic solution 5.0% was the first medication approved by the US FDA for treatment of the signs and symptoms of DED. We developed and validated two novel, economic, specific, and sensitive UV spectrophotometric and RP-HPLC methods for estimation of lifitegrast in bulk and dosage form. The linearity was found in the concentration range of 05-30 μg/mL in UV method (R²=0.9995) and 2-12 μg/mL in HPLC method (R²=0.999) with good correlation coefficient. The LOD and LOQ were found to be 0.77 μg/mL and 2.33 μg/mL, respectively by UV method. RP-HPLC method was developed at SunFire C 18 column (250 × 4.6 mm i.d., 5μm) using methanol, acetonitrile, and water as a mobile phase in the ratio of 20:60:20 (v/v) (pH = 2.27 adjusted with orthophosphoric acid). The LOD and LOQ were found to be 0.50 μg/mL and 1.52 μg/mL respectively by HPLC method. These developed methods were validated according to ICH (Q2 (R1)) guidelines with the following validation parameters i.e., specificity, linearity, accuracy, precision, LOD, LOQ, robustness, and ruggedness. The results of the study proved the applicability of the method in routine analysis of lifitegrast.

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“…Известны методики качественного и количественного определения фексофенадина гидрохлорида в одной лекарственной форме с монтелукастом натрия и амброксола гидрохлоридом в изократическом режиме элюирования смесью метанол:вода (70:30) и УФ-детекцией [31] Таким образом, на основании литературных данных в настоящем исследовании для качественного и количественного определения активных субстанций фексофенадина гидрохлорида и аммония глицирризината был использован метод высокоэффективной жидкостной хроматографии с УФ-детектированием. В ходе работы было показано, что в силу различной растворимости целевых субстанций, изократический режим элюирования не позволяет достичь оптимального разделения компонентов при продолжительности анализа менее 30 минут, что определило использование градиентного режима.…”

Section: результаты и обсуждение разработка методики количественного определения фексофенадина гидрохлорида и аммония глицирризината при unclassified

Development and Validation of Methods for Quantitative Determination of Active Pharmaceutical Substances in Nasal Spray

Ларский

Позднякова

Хаджиева

et al. 2021

Farm. farmakol. (Pâtigorsk)

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Intranasal administration of H1-histamine receptor blockers may be a promising approach to the treatment of allergic rhinitis. Earlier, an original composition of a nasal spray containing fexofenadine hydrochloride and ammonium glycyrrhizinate and demonstrating a high level of therapeutic efficacy, was developed.The aim of the study was to develop and validate a method of the quantitative determination of active pharmaceutical ingredients fexofenadine hydrochloride and ammonium glycyrrhizinate in a spray for intranasal administration.Materials and methods. During the development and validation of the method of the fexofenadine hydrochloride and ammonium glycyrrhizinate quantitative determination in a nasal spray, the method of high performance liquid chromatography was used: a Dionex Ultimate 3000 UV chromatograph with a Luna C18 column (2) containing octadecylsilicagel with a 5 μm grain size as a sorbent. The analysis and validation procedures were performed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, the XIVth edition.Results. The study showed that for the simultaneous quantitative determination of fexofenadine hydrochloride and ammonium glycyrrhizinate, the optimal elution regime is a gradient mode with a mobile phase containing 50 mmol/L potassium dihydrogen phosphate solution with methanol (45:55), which ensured the separation of the components in the 20 minutes interval. The validation procedures showed that the developed methodology correspond to all the criteria of validity in terms of the following indicators: correctness, precision, specificity and linearity in the analytical area.Conclusion. The obtained results indicate the possibility of using the method of high-performance liquid chromatography in a gradient elution mode with a mobile phase of the composition of a 50 mmol/L solution of potassium dihydrogen phosphate with methanol (45:55) for the simultaneous quantitative determination of active pharmaceutical ingredients – fexofenadine hydrochloride and ammonium glycyrrhizinate as parts of a promising nasal spray for the allergic rhinitis treatment.

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Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for Simultaneous Estimation of Fexofenadine Hydrochloride, Montelukast Sodium and Ambroxol Hydrochloride in Tablet Dosage Form

Cited by 8 publications

References 15 publications

An analytical review for the estimation of montelukast sodium

An analytical review for the estimation of montelukast sodium

A Validated Method Developed for Estimation of Lifitegrast in Bulk and Pharmaceutical Dosage Form by UV-Spectrophotometer and RP-HPLC

Development and Validation of Methods for Quantitative Determination of Active Pharmaceutical Substances in Nasal Spray

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