Development and validation of RP-HPLC method with ultraviolet detection for estimation of montelukast in rabbit plasma: Application to preclinical pharmacokinetics

Ranjan, Om Prakash; Nayak, Usha Y.; Reddy, M. Sreenivasa; Dengale, Swapnil J.; Musmade, Prashant B; Udupa, N.

doi:10.1016/j.jyp.2013.10.006

Cited by 11 publications

(9 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The method developed using the other option exhibited the best resolution between known impurities, and degradation peaks of Montelukast Sodium. The wavelength (220 nm) used in the method exhibited best separation and absorption measurements, provided its optimal values [19][20][21].…”

Section: Methods Developmentmentioning

confidence: 99%

A Novel Stability-Indicating Method for Determination of Related Substances of Montelukast Sodium in a Pharmaceutical Dosage Form Using RP-HPLC

et al. 2021

View full text Add to dashboard Cite

The main aim is to develop a simple, rugged, and sensitive method for determining the Montelukast Sodium-related impurities in a tablet dosage form using reverse-phase high-performance liquid chromatography (RP-HPLC) method. Chromatographic separation on the Agilent Eclipse XDB C18 (octadecylsilane) column of the dimension (100 mm × 4.6 mm, 5 µm) was carried out in the gradient mode with triethylamine and acetonitrile in various combinations and adjusted to a pH of 6.60 using phosphoric acid. The mobile phase was pumped at a flow rate of 1.0 mL min −1 and the analyte was monitored with a UV detector at a wavelength of 220 nm. The method was developed and validated under the stress conditions such as acidic, basic, peroxide, thermal, photolytic, and humidity degradation, respectively. Under the above conditions, oxidative degradation was performed which served as the system suitability solution providing a resolution of 2.5 between the Impurity 3 (retention time = 13.8 min) and Montelukast Sodium (retention time = 24.2 min). The method was validated with respect to specificity, linearity, precision, accuracy, limit of detection, and limit of quantification provided by the ICH guidelines. Results of linear regression analysis of the calibration plot revealed a good linear relationship between response and concentration with a correlation coefficient value of r 2 = 0.9999. The accuracy of known impurities was obtained in the range of 94-108%. From the analysis, their LOD and LOQ values for impurities were measured and found to be 0.007 and 0.025 μg g −1 , respectively. Chromatographic interference was not found during the degradation and excipients were detected from the tablet. The proposed method was successfully used to estimate the Montelukast Sodium-related impurities in a tablet dosage form.

show abstract

Section: Methods Developmentmentioning

confidence: 99%

A Novel Stability-Indicating Method for Determination of Related Substances of Montelukast Sodium in a Pharmaceutical Dosage Form Using RP-HPLC

et al. 2021

View full text Add to dashboard Cite

show abstract

“…The bioanalytical method was adopted as described earlier by Ranjan et al, 2013, andShafaati et al, 2010, after performing partial method validation [12,13].…”

Section: Singh Et Almentioning

confidence: 99%

“…The mixture was vortexed for 15 min followed by centrifugation at −4°C, 8000 rpm for 20 min. Finally, I injected 20 µl of supernatant into HPLC column [12,13].…”

Section: Plasma Sample Preparation For Calibration Curvementioning

confidence: 99%

Pharmacokinetic Comparison of Montelukast Sodium Formulations After a Single Oral Dose in Healthy Guinea Pigs

Singh¹,

Kumar²,

Kulkarni

2019

Asian J Pharm Clin Res

View full text Add to dashboard Cite

Objective: Pharmacokinetic evaluation of montelukast sodium chronomodulated capsules (sustained-release solid dispersion of drug enclosed in pH-sensitive film-coated hard gelatin shell) and marketed tablets has been carried out in this study. Methods: A single oral dose of prepared capsules and marketed conventional tablets was administered in healthy male Dunkin-Hartley albino guinea pigs. Blood samples were collected at different time intervals and plasma concentration of drug was determined by reversed-phase high-performance liquid chromatography. Different pharmacokinetic parameters were assessed from plasma drug concentration-time profile by one-compartment model, first-order kinetics. Results: Pharmacokinetic parameters such as time to reach maximum concentration, elimination rate constant, elimination half-life, and mean residence time data indicates that drug release from chronomodulated capsules is significantly prolonged with initial release lag time of 3.5–4 h in comparison with marketed conventional tablets. However, maximum drug plasma concentration, area under the concentration-time curve, and apparent volume of distribution values show non-significant difference between capsules and marketed tablets. Conclusion: The findings specified that capsules were providing time controlled delivery of drug at a desired rate for prolonged time, which may be helpful for the prevention of episodic attack of asthma in early morning hours.

show abstract

“…Method development for the formation of pharmacokinetic profiles typically focuses on high‐throughput, highly sensitive techniques (Roberts, 2001; Sharma et al, 2017). These methods generally employ HPLC coupled to either UV or mass spectrometry (MS) detection and are developed with the primary focus of resolving one or two analytes of interest (Gu et al, 2010; Mao et al, 2007; Ranjan et al, 2013). When involving MS, the industry standard approach utilizes targeted MS/MS analyses using triple quadrupole mass spectrometers owing to their sensitivity and specificity (Ananthula et al, 2015; Dubey & Ghosh, 2015; Goldwirt et al, 2013; Lin et al, 2013; Ocque et al, 2019).…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic and metabolic analysis of an Alzheimer's disease therapeutic in rat serum via microfluidic CZE–MS

Kelley

Lovell

Lynn

2021

Biomedical Chromatography

View full text Add to dashboard Cite

Sensitive, high‐throughput methods for pharmacokinetic (PK) profiling are essential for potential therapeutics during critical stages of clinical trials. The application of a microfluidic capillary zone electrophoresis mass spectrometry (CZE–MS) method for PK profiling allows for rapid, sensitive and in‐depth analysis of multiple samples within a short timeframe. Here, a CZE–MS approach for PK analysis was compared with a traditional UHPLC–MS approach when analyzing serum extracts from rats treated with a potential Alzheimer's disease therapeutic, BNC‐1. Resulting PK data generated from both methods displayed statistical similarities. Additionally, the separation efficiency attributed to the use of the CZE–MS method provided substantial metabolic regulation data that was not apparent in the UHPLC–MS method. Additionally, the coupling of the CZE–MS method to the data processing software, MZmine2, was used to monitor changes in metabolism and observe putative BNC‐1‐derived metabolites. The ability to perform fast analyses without sacrificing sensitivity or metabolic information suggests that this CZE–MS method is ideal for metabolomics‐inclusive, high‐throughput PK profiling.

show abstract

Development and validation of RP-HPLC method with ultraviolet detection for estimation of montelukast in rabbit plasma: Application to preclinical pharmacokinetics

Cited by 11 publications

References 16 publications

A Novel Stability-Indicating Method for Determination of Related Substances of Montelukast Sodium in a Pharmaceutical Dosage Form Using RP-HPLC

A Novel Stability-Indicating Method for Determination of Related Substances of Montelukast Sodium in a Pharmaceutical Dosage Form Using RP-HPLC

Pharmacokinetic Comparison of Montelukast Sodium Formulations After a Single Oral Dose in Healthy Guinea Pigs

Pharmacokinetic and metabolic analysis of an Alzheimer's disease therapeutic in rat serum via microfluidic CZE–MS

Contact Info

Product

Resources

About