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(searched for: doi:10.5530/ptb.2016.2.2)
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Kamini Sethy, K. Raja Rajeswari,
Published: 15 June 2022
Asian journal of Chemistry, Volume 34, pp 1779-1787; https://doi.org/10.14233/ajchem.2022.23724

Abstract:
A new HPLC stability indicating method was developed and optimized by using a statistical tool, design expert 13.0.1.0 (Stat-Ease) for simultaneous quantitation of bilastine and montelucast sodium in marketed tablet dosage form. Randomized response surface methodology with two factor central composite design was utilized for mobile phase optimization and the effect of the independent variables, flow rate and volume of organic phase on critical quality attributes, resolution and retention time was studied. The analytes were resolved on a inertsil C18 (150 × 4.6 mm) column with 5 μm particle size. Within the design space the optimum chromatographic condition chosen was 0.1% orthophosphoric acid with acetonitrile at 60:40 (%v/v) having a flow rate of 1 min/mL for 10 min. The retention time (Rt) for bilastine and montelucast sodium was 2.445 and 3.787 min, respectively. The method was completely validated as per the current ICH guidelines. Forced degradation was carried out in acidic, basic, photolytic, neutral, oxidation, thermal conditions to prove the stability indicating property of HPLC method. The method’s applicability was studied by determining bilastine and montelucast sodium in the marketed tablet dosage form. This validated RP-HPLC stability indicating method can be suggested for routine quality control analysis in industries and research laboratories for the fixed dose marketed tablet formulation.
Arjun Anant, Moumita Saha, Shubham Dhiman, Priti Singh, Balak Das Kurmi, Ghanshyam Das Gupta,
Published: 2 March 2022
Separation Science Plus, Volume 5, pp 120-137; https://doi.org/10.1002/sscp.202100069

Pinkal Patel, Zinal A. Panchal, Sweta Patel, Dipti Patel
Published: 28 December 2021
Research Journal of Pharmacy and Technology, Volume 14, pp 6761-6767; https://doi.org/10.52711/0974-360x.2021.01167

Abstract:
Allergic rhinitis (AR) is a heterogeneous disorder that despite its high prevalence is often undiagnosed. It is characterized by one or more symptoms including sneezing, itching, nasal congestion and rhinorrhea. Many causative agents have been linked to allergic rhinitis (AR) including pollens, molds, dust mites and animal dander allergy. Montelukast and bilastine are used in the treatment of allergic rhinitis (AR). Montelukast and bilastine each drug reveals in vivo and in vitro. They are generally administrated as tablets. Determination of montelukast and bilastine in bulk dosage form, tablet dosage form and pharmaceutical dosage form. Method indicating human plasma stability and impurity profiling are also described for Montelukast and Bilastine drugs. Several analytical methods including UV, HPTLC and HPLC method has been developed. Estimation of montelukast and bilastine for quantitative and qualitative method can be used. In this review methods for determination of montelukast and bilastine in alone and in combination by UV and RP-HPLC techniques. This review covers most recent analytical methods such as various spectroscopic methods, chromatographic methods and other methods for determination of Montelukast and Bilastine in various pharmaceutical dosage forms. The following study illustrate the review on analytical method which includes estimating the anti-histamines drugs.
, Pankti A. Patel, Usmangani Chhalotiya
JPC – Journal of Planar Chromatography – Modern TLC, Volume 34, pp 289-295; https://doi.org/10.1007/s00764-021-00120-w

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Journal of Analytical Methods in Chemistry, Volume 2021, pp 1-8; https://doi.org/10.1155/2021/5540907

Abstract:
In this study, we present a new, green electrochemical method for potentiometric estimation of desloratadine and montelukast sodium in their pure and binary dosage form. For that, three pencil graphite sensors were fabricated; the first one was prepared to analyse desloratadine drug (DES) by coating the graphite bar with the coating membrane, which comprises the ion pair of desloratadine and ammonium reineckate reagent (RNK), the polymer poly vinyl chloride (PVC), and the plasticizers dibutyl phthalate (DBP). The second one, which was used to analyse montelukast (MON), was constructed by using the ion pair of cadmium chloride reagent (Cd.) with montelukast and the same earlier named polymer and plasticizer. As a trial to analyse both of the drugs by the same sensor consecutively, we have constructed a combined pencil graphite electrode, which contains the two earlier suggested ion pairs, that is, we can use this electrode to selectively analyse for each drug. The proposed electrodes were effectively used for analysis of DES and MON as a single dosage form and as combined pharmaceutical preparation, without any need for prior separation that was performed depending on the difference in the efficient pH range for each sensor. The proposed sensors exhibited a Nernstian equation slopes of −30.11, 27.70, (−29.16, 29.79) mv. decade−1 in the linearity range 5.00 × 10−5−1.00 × 10−2 and 1.00 × 10−5 − 1.00 × 10−2 M, respectively. The sensors exhibit high sensitivity according to LOD values ((0.036–0.018) − (0.025-0.026) µM), respectively, and important selectivity toward the studied drugs in presence of interfering ions and excipients. The optimum circumstances were studied, and the method was validated by application of ICH rules. Finally, the method was compared with a documented method, and the required statistical values were calculated.
Published: 19 October 2020
Journal: BMC Chemistry
BMC Chemistry, Volume 14, pp 1-9; https://doi.org/10.1186/s13065-020-00716-z

Abstract:
This paper introduces the first electrochemical approach for the determination of Fexofenadine hydrochloride and Montelukast sodium as a combined form by constructing three new graphite electrodes coated with a polymeric membrane. The first electrode was constructed using ammonium molybdate reagent as an ion pair with fexofenadine cation for the determination of Fexofenadine drug, the second electrode was constructed using cobalt nitrate as an ion pair with montelukast anion for the determination of Montelukast drug, the third electrode was prepared by incorporating the two previously mentioned ion pairs in the same graphite sensor, which makes this sensor sensitive to each Fexofenadine and Montelukast drug. The coating material was a polymeric film comprises of Poly Vinyl Chloride (PVC), Di-butyl phthalate as a plasticizer (DBP), ion pairs of drugs with previously mentioned reagents. The electrodes showed a Nernstian response with a mean calibration graph slopes of [59.227, 28.430, (59.048, 28,643)] mv.decade−1 for the three pencil electrodes respectively, with detection limits 0.025 μM for Fexofenadine and 0.019 μM for Montelukast drug which makes this method outperforms the reported method for the determination of this combination. The electrodes work effectively over pH range (2–4.5) for Fexofenadine hydrochloride and (5–9.5) for Montelukast sodium. The influence of the proposed interfering species was negligible as shown by selectivity coefficient values. The effectiveness of the electrodes continued in a period of time (45–69) days. The suggested sensors demonstrated useful analytical features for the determination of both drugs in bulk powder, in laboratory prepared mixtures and their combined dosage form. We have validated the method following ICH protocol, and we have reached very significant results in terms of the linearity, accuracy, selectivity, and precision of the method.
, Vinoth Kumar
Published: 3 January 2020
Critical Reviews in Analytical Chemistry, Volume 51, pp 232-245; https://doi.org/10.1080/10408347.2019.1709410

Abstract:
Fexofenadine hydrochloride is an antihistamine agent used for the treatment of allergic disorders like rhinitis. It is a second generation antihistamine. Montelukast sodium is an anti-asthmatic agent and leukotriene receptor antagonist used in the treatment of respiratory disorders. This article exemplifies the reported analytical methods like electrometric methods, ultraviolet spectroscopy, mass spectroscopy, thin layer chromatography, high performance liquid chromatography, high performance thin layer chromatography and tandem spectroscopy for determination of fexofenadine HCl and montelukast sodium in dosage form and in biological matrices. This review covers almost all the analytical methods for fexofenadine hydrochloride and montelukast sodium form 1968-2018 years. Complete analytical validation parameters reported are discussed in this review for both analytes. Among various analytical methods, HPLC and UV-visible spectrophotometry were found to be the most extensively used methods by the researchers.
, Noha N. Atia, Samia M. El-Gizawy, Dalia M. Badary, Mohammad S. Hareedy
Published: 16 August 2018
Journal: The Analyst
The Analyst, Volume 143, pp 4366-4378; https://doi.org/10.1039/c8an00772a

Abstract:
This study was designed to evaluate the potential protective effects of montelukast, febuxostat and their combination on a model of acute gouty arthritis, and to establish a HPTLC method for determination of both drugs simultaneously.
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