Validation of assay indicating method development of meloxicam in bulk and some of its tablet dosage forms by RP-HPLC

Sahoo, Nalini Kanta; Sahu, Madhusmita; Rao, Podilapu Srinivasa; Rani, Neetika; Devi, Jnv Indira; Ghosh, Goutam

doi:10.1186/2193-1801-3-95

Cited by 12 publications

(9 citation statements)

References 9 publications

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“…Plentiful UV-VIS, HPLC, HPLC-MS/MS, LC-MS, LC-MS-MS, LC-ESI-MS/MS, LC-MS/TOF, and LC-MS analytical methods have been documented for quantifying the MLC from different formulation either alone or in combination with pharmacotherapeutic agents in biological fluid [1,[4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]; a couple of them namely were employed liquid-liquid extraction or protein precipitation extraction (PPE) approach for quantification of MLC from biological sample [5,7,14]. In spite of that, the reported approaches are time-consuming; some of them used organic solvents and hazardous solvents for the extraction process, and some of which reported much less recovery which may be due to the drug loss during the transfer.…”

Section: Introductionmentioning

confidence: 99%

“…Though solidphase extraction has been reported by Miyamoto et al to quantify the MLC from biological sample, this method requires expensive equipment [1]. Couple of the bioanalytical methods used to quantify the MLC did not use the internal standard, which seemed to be a limitation of the reported method; some of which had been used but were complex in nature [8,11,12,15,17].…”

Section: Introductionmentioning

confidence: 99%

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Meloxicam quantification in rabbit plasma by RP-HPLC: optimization and application to pharmacokinetic study

Salunkhe

Jadhav

Bhinge³

2020

Futur J Pharm Sci

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Background The goal of the proposed study was to validate a rapid, simple, an accurate, robust, and sensitive bioanalytical method for quantifying Meloxicam and Lornoxicam (as internal standard) in rabbit plasma. Result Limit of detection and limit of quantification for Meloxicam were found to be 0.0081 and 0.1035 μg mL−1, respectively. The bioanalysis was continued according to standard guidelines and successfully used for bioavailability studies of meloxicam after single dose administration of pure drug and the formulation in rabbit plasma. Finally, obtained results proved its simplicity and an efficiency to be applied for the therapeutic drug monitoring and bioequivalence studies. Conclusion Therefore, the set RP-HPLC bioanalysis is simple, convenient, and acceptable to analyze meloxicam in bulk and pharmaceutical formulations in rabbit plasma. Graphical abstract

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Meloxicam quantification in rabbit plasma by RP-HPLC: optimization and application to pharmacokinetic study

Salunkhe

Jadhav

Bhinge³

2020

Futur J Pharm Sci

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“…Analytical, bioanalytical methods have been reported for the estimation of SIM alone or in combination with other antihypertensive agents or antihyperlipidemic drugs of pharmaceutical formulations. These include reverse-phase high-performance liquid chromatography (RP-HPLC) [5][6][7][8][9], bioanalytical HPLC method [10,11], bioanalytical LC-mass spectrometry (MS)/MS method [12,13], and solubility enhancement method [14].…”

Section: Introductionmentioning

confidence: 99%

Simple Bioanalytical Quantification Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Human Plasma by Reverse-Phase High-Performance Liquid Chromatography Technique

Gk¹,

Rl²

2019

Asian J Pharm Clin Res

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Objective: A bioanalytical quantification method was developed for the simultaneous estimation of simvastatin (SIM) and ezetimibe (EZE) from the human plasma. Methods: The technique was developed and equipped with reverse-phase (RP) high-performance liquid chromatography, using RP-C18 column with an ultraviolet detector. For the estimation of SIM and EZE, the mobile phase (acetonitrile:acetate buffer pH 4.0, pH adjusted with acetic acid) was pumped at a flow rate of 0.8 ml/min in the ratio of 85:15% v/v and the eluents were monitored at 234 nm. A calibration graph to study linearity of the SIM and EZE in biological matrix was carried out in the concentration range of 400–4000 ng/ml for both these drugs SIM and EZE. Results: The developed method was validated according to the US FDA and European Medicines Agency guidelines for sensitivity, accuracy, precision, and stability. The obtained statistical data of validation were found to be within prescribed limit assures rigidity of the method. Both the drugs in combined form were estimated in human plasma by the proposed method. Conclusions: The developed method is free from solid-phase extraction so it becomes simple and economical. The method is efficient for precise and accurate quantification of SIM and EZE in plasma and hence applied for bioequivalence, bioavailability study in real clinical samples.

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“…These methods are essential to determine the drug content incorporated into them. Some methods for the quantification of meloxicam in pharmaceutical forms by HPLC method are described in the literature (Zhang, Choi, 2008;Bandarkar, Vavia, 2009;Sahoo et al, 2014). However, there is no specific methodology for nanostructured systems containing meloxicam.…”

Section: Introductionmentioning

confidence: 99%

Validation of high performance liquid chromatography method for determination of meloxicam loaded PEGylated nanocapsules

Ianiski

Laporta

Rubim

et al. 2015

Braz. J. Pharm. Sci.

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A method to ensure that an analytical method will produce reliable and interpretable information about the sample must first be validated, making sure that the results can be trusted and traced. In this study, we propose to validate an analytical high performance liquid chromatography (HPLC) method for the quantitation of meloxicam loaded PEGylated nanocapsules(M-PEGNC). We performed a validation study, evaluated parameters including specificity, linearity, quantification limit, detection limit, accuracy, precision and robustness. PEGylated nanocapsules were prepared by interfacial deposition of preformed polymer, and the particle size, polydispersity index, zeta potential, pH value and encapsulation efficiency were characterized. The proposed HPLC method provides selective, linear results in the range of 1.0-40.0 μg/mL; quantification and detection limits were 1.78 μg/mL and 0.59 μg/mL, respectively; relative standard deviation for repeatability was 1.35% and intermediate precision was 0.41% and 0.61% for analyst 1 and analyst 2, respectively; accuracy between 99.23 and 101.79%; robustness between 97.13 and 98.45% for the quantification of M-PEGNC. Mean particle diameters were 261 ± 13 nm and 249 ± 20 nm, polydispersity index was 0.15 ± 0.07 and 0.17 ± 0.06, pH values were 5.0 ± 0.2 and 5.2 ± 0.1, and zeta-potential values were -37.9 ± 3.2 mV e -31.8 ± 2.8 mV for M-PEGNC and placebo(B-PEGNC), respectively. In conclusion, the proposed analytical method is suitable for the quality control of M-PEGNC. Moreover, suspensions showed monomodal size distributions and low polydispersity index indicating high homogeneity of formulations with narrow size distributions, and appropriate pH and zeta potential. The extraction process was efficient for release of meloxicam from nanostructured systems.Uniterms: High performance liquid chromatography/quantitative analysis. Meloxicam/determination. PEGylated nanocapsules/quality control. Nanoparticles. Poly(ethylene glycol).Para se assegurar que um método analítico produzirá informação confiável e interpretável sobre a amostra este deve ser inicialmente validado, tornando claro que os resultados podem ser confiados e rastreados. Neste estudo, propomos validar um método de cromatografia líquida de alta eficiência (CLAE) para a quantificação do meloxicam encapsulado em nanocápsulas PEGuiladas (M-PEGNC). Efetuamos a validação, avaliando parâmetros de especificidade, linearidade, limite de quantificação, limite de detecção, exatidão, precisão e robustez. As nanocápsulas PEGuiladas foram preparadas por deposição interfacial do polímero pré-formado e caracterizaram-se o tamanho da partícula, índice de polidispersão, potencial zeta, pH e eficiência de encapsulação. O método de CLAE proposto fornece resultados seletivos e lineares na faixa de 1,0-40,0 mg/mL; limites de quantificação e detecção de 1,78 mg/mL e 0,59 mg/mL, respectivamente; desvio padrão relativo para a repetibilidade de 1,35% e precisão intermediária de 0,41% e 0,61% para o analista 1 e analista 2, respectivamente; exatidã...

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Validation of assay indicating method development of meloxicam in bulk and some of its tablet dosage forms by RP-HPLC

Cited by 12 publications

References 9 publications

Meloxicam quantification in rabbit plasma by RP-HPLC: optimization and application to pharmacokinetic study

Meloxicam quantification in rabbit plasma by RP-HPLC: optimization and application to pharmacokinetic study

Simple Bioanalytical Quantification Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Human Plasma by Reverse-Phase High-Performance Liquid Chromatography Technique

Validation of high performance liquid chromatography method for determination of meloxicam loaded PEGylated nanocapsules

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