In depth investigation of analytical methods for the determination of montelukast and bilastine in biological fluid and pharmaceutical dosage forms: A Review

Patel, Pinkal; Panchal, Zinal A.; Patel, Shivani; Patel, Dipti

doi:10.52711/0974-360x.2021.01167

Cited by 4 publications

(3 citation statements)

References 25 publications

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“…Stress studies were conducted under ICH‐recommended guidelines to evaluate the proposed analytical method's stability‐indicating property. Stress degradation studies of APR were carried out by subjecting the drug sample to acidic, basic, photolytic, oxidative, and heat conditions [46–50].…”

Section: Methodsmentioning

confidence: 99%

Novel Stability–Indicating Reverse‐Phase High‐Performance Liquid Chromatography Technique for Apremilast Quantification in Pharmaceuticals and Nanovesicular Systems: A Design of Experiment Approach

Sutar,

Jalalpure,

Kurangi

2024

Separation Science Plus

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An accurate and precise reverse‐phase high‐performance liquid chromatographic technique for apremilast (APR) quantification in bulk, commercial tablets, and formulated APR‐loaded nanoformulations was developed and validated by the design of the experiment approach in accordance with the International Conference of Harmonization guidelines. APR was separated by using formic acid buffer (0.1%; pH 3.2):methanol (40:60, v/v) as a solvent system with a flow rate of 1 mL/min and was detected at a wavelength of 230 nm with a retention time of 7.1 min. The central composite design was employed to optimize the developed analytical method. The calibration curve for APR was linear (r2 = 0.999), with a limit of detection of 0.5 µg/mL and a limit of quantification of 1.52 µg/mL, respectively. A recovery of APR in tablet and nanoformulation was observed in the 98.56%–99.32% range. Forced degradation studies revealed the stability of the proposed analytical method, as the APR peak remained unchanged under stress‐induced degradation experiments. Hence, the proposed chromatographic technique with a cost‐effective solvent system could be employed in the pharmaceutical industry for estimating APR in various formulations.

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Section: Methodsmentioning

confidence: 99%

Novel Stability–Indicating Reverse‐Phase High‐Performance Liquid Chromatography Technique for Apremilast Quantification in Pharmaceuticals and Nanovesicular Systems: A Design of Experiment Approach

Sutar,

Jalalpure,

Kurangi

2024

Separation Science Plus

View full text Add to dashboard Cite

show abstract

“…8,[9][10][11][12][13] There were also a few other RP-HPLC and UV methods for analysing MTL and BST simultaneously time in bulk mixtures and combined dosage forms. [14][15][16][17][18][19][20][21] There are a few problems with the reported method, such as longer retention times for either MTL or BST and gradient elution. 19,20 Few of the reported methods did not have stability tests done.…”

Section: Figure -1: 1 Chemical Mtl Structures Of and Bstmentioning

confidence: 99%

“…The %purities of MTL and BST the in sample solution were determined by injecting successive injections of standard and sample solution 16 .…”

Section: Assaymentioning

confidence: 99%

Estimation of bilastine and montelukast by stability indicating liquid chromatographic method in pure binary mixture and their marketed tablets

Kunala

Gummadi

2022

ijhs

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The main objective of the current work is to develop and validate a new RP-HPLC method for estimation of Bilastine and Montelukast in bulk and in their combined tablets. A good separation of both analytes in various types solutions was attained by using a Ascentis C18 (150 x 4.6mm, 2.6µ) column with a solvent or mobile phase of 0.1% OPA: acetonitrile (50:50 v/v) at a flow rate of 1ml/min and a detection wavelength of 230nm. To test the stability of the analytes, the drug substance was put in an environment with a lot of stress, such as hydrolysis with acid and base, peroxide oxidation, and thermal degradation. At at 2.25min and 2.78 min, Bilastine and Montelukast were eluted with isocratic elution. The method is expected to show a linear response from 2.5 to 15µg/ml for Bilastine and from 5 to 30 µg/ml for Montelukast. Bilastine's LOD and LOQ were establishe to be 0.1and 0.31µg/ml, while Montelukast's were 0.3 and 0.91µg/ml. From the Bilastine and Montelukast peaks, the degradant peaks that were made were easy to tell apart. The method was very sensitive, accurate, cost-effective, and showed stability.

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Green quality by design HPLC approach for the simultaneous determination of Bilastine and Montelukast

et al. 2023

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For the simultaneous estimation of two co-formulated antihistaminic drugs (Bilastine and Montelukast), a novel and eco-friendly reversed-phase HPLC approach with both diode array and fluorescence detection modes was designed. Rather than using the routine methodology, the Quality by Design (QbD) approach was adopted to speed up the method development and to test robustness of the method. To evaluate the effect of variable factors on chromatographic response, a full factorial design was used. The chromatographic separation was performed using isocratic elution on the C18 column. The mobile phase consists of 92% methanol, 6% acetonitrile, and 2% phosphate buffer with 0.1 (v/v) triethylamine adjusted to pH 3, it was pumped at a flow rate of 0.8 mL/min with an injection volume of 20 μL. The developed stability indicating HPLC approach was used to assess the stability of montelukast (MNT). It was subjected to a variety of stress conditions, including hydrolytic (acid–base), oxidative, thermal, and photolytic stress conditions. All of these conditions were found to have relevant degradation pathways. Under the described experimental conditions, MNT degradation followed pseudo-first-order kinetics. The kinetic parameters of its degradation (rate constant and t1/2) were calculated and a proposal for the degradation pathway was postulated.

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In depth investigation of analytical methods for the determination of montelukast and bilastine in biological fluid and pharmaceutical dosage forms: A Review

Cited by 4 publications

References 25 publications

Novel Stability–Indicating Reverse‐Phase High‐Performance Liquid Chromatography Technique for Apremilast Quantification in Pharmaceuticals and Nanovesicular Systems: A Design of Experiment Approach

Novel Stability–Indicating Reverse‐Phase High‐Performance Liquid Chromatography Technique for Apremilast Quantification in Pharmaceuticals and Nanovesicular Systems: A Design of Experiment Approach

Estimation of bilastine and montelukast by stability indicating liquid chromatographic method in pure binary mixture and their marketed tablets

Green quality by design HPLC approach for the simultaneous determination of Bilastine and Montelukast

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