Development and Validation of Spectrophotometric Methods for the Assay of Mirabegron in Bulk and Pharmaceutical Formulations

Roopa, K. P.; Basavaiah, K.; Shankara, B. S.; Mahesh, B.

doi:10.1007/s10812-021-01126-2

Cited by 10 publications

(1 citation statement)

References 11 publications

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“…The research was conducted on the Blend Uniformity (BU) stage, with finished product stage formulation samples, and developed a quantification method for MBN. Several authors have reported several methods for MBN quantification by spectrophotometric estimation (Morshedy et al, 2020; Papanna et al, 2018; Rao et al, 2017; Roopa et al, 2021). Few authors have reported a UV spectrophotometric method for bulk drug analysis (Ravisankar et al, 2016; Suresh et al, 2020) or LC/MS and thin‐layer chromatography methods for clinical analysis (Shah et al, 2019; Van Teijlingen et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

Unique liquid chromatography technique for the determination of mirabegron in the presence of polymers; robustness by Design Expert in the light of Quality by Design

Konduru¹,

Kowtharapu

Gundla

2022

Biomedical Chromatography

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The current study is designed to estimate mirabegron in the presence of high molecular weight polymers using a unique liquid chromatography method and sample preparation technique. The proposed method is significant because of the many analytical issues faced during the development studies. Based on the experimental results, we finally achieved the stability-indicating power of the method. The adequately prepared mobile phase was in the ratio of pH 2.0 buffer and acetonitrile (80:20) v/v, and the buffer pH 2.0 was prepared as follows: 8.7 ml of perchloric acid, 2 ml of triethylamine and 3.0 g sodium hydroxide into 1 L of water mixed well. The system suitability parameters were achieved using a Waters X-Bridge C 18 (4.6 Â 150 mm, 3.5 μm) column and mobile phase. The optimized chromatographic conditions included a column temperature of 45 C, a flow rate of 1.0 ml min À1 ; an injection volume of 5 μl, UV 247 nm, and 15 min runtime. The method was validated and transferred to quality control as per International Conference on Harmonization Q2(R1) and the Chinese Pharmacopoeia 2020 edition <9101> and <9100>. The recovery and linearity results were obtained between 99.0 and 101.0%; the value of r 2 was 0.9998. The method robustness study was established by utilizing the Design of Experiments part of the Quality by Design concept. The method's stability-indicating nature was proved by a forced degradation study; all of the conditions for analyte peak purity were passed, and mass balance was achieved. The method was used to determine mirabegron assay, as well as content uniformity, blend uniformity and cleaning samples. It is a user-friendly and cost-effective method.

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Section: Introductionmentioning

confidence: 99%

Unique liquid chromatography technique for the determination of mirabegron in the presence of polymers; robustness by Design Expert in the light of Quality by Design

Konduru¹,

Kowtharapu

Gundla

2022

Biomedical Chromatography

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An Eco‐Friendly and Sensitive Microwave‐Aided Spectrofluorophotometric Characterization of Mirabegron‐Loaded Nanocarriers by Amalgamation of Design of Experiments and White Analytical Chemistry

Prajapati,

Patel,

Shah

et al. 2024

Luminescence

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Mirabegron, a drug for treatment of overactive bladder, has low water solubility and bioavailability. Researchers used quality by design to develop and characterize second‐generation lipid nanocarriers for mirabegron, aiming to provide spatially and temporally sustained drug release. Numerous analytical methodologies for assessing mirabegron in pharmaceutical and biological fluids use chemical solvents in the mobile phase, potentially impacting aquatic ecosystems and the environment. The issue was addressed with a microwave‐assisted spectrofluorimetric technique, environmentally benign solvents, and a fluorescent probe known as 4‐chloro‐7‐nitrobenzofuran. Researchers used screening design and response‐surface methodology to minimize organic waste. The suggested technique satisfied ICH Q2 (R2) and M10 validation standards. This approach described the in vivo pharmacokinetics and in vitro drug release of mirabegron‐loaded lipid nano‐carriers. We anticipated the chemical reaction pathways that derivatized mirabegron with 4‐chloro‐7‐nitrobenzofuran by the analysis of mass spectra. We assessed the proposed method's environmental effect and sustainability compared to current methods using the RGB model, an analytical greenness calculator, and green analytical process index software. The proposed mirabegron estimate method was user‐friendly for analysts, cost‐effective, sensitive, robust, and environmentally sustainable, adhering to sustainable analytical practices and reducing ecological consequences.

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Determination of Vardenafil in Pure and Dosage Forms by Spectrophotometry

Roopa¹,

Keshavamurthy

Mahesh

et al. 2022

J Appl Spectrosc

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Development and Validation of Spectrophotometric Methods for the Assay of Mirabegron in Bulk and Pharmaceutical Formulations

Cited by 10 publications

References 11 publications

Unique liquid chromatography technique for the determination of mirabegron in the presence of polymers; robustness by Design Expert in the light of Quality by Design

Unique liquid chromatography technique for the determination of mirabegron in the presence of polymers; robustness by Design Expert in the light of Quality by Design

An Eco‐Friendly and Sensitive Microwave‐Aided Spectrofluorophotometric Characterization of Mirabegron‐Loaded Nanocarriers by Amalgamation of Design of Experiments and White Analytical Chemistry

Determination of Vardenafil in Pure and Dosage Forms by Spectrophotometry

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