Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fosamprenavir Calcium in Pure and Pharmaceutical Dosage Forms

Rao, Nagasarapu Mallikarjuna; Sankar, D. Gowri

doi:10.14233/ajchem.2015.19007

Cited by 9 publications

(6 citation statements)

References 12 publications

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“…Antiviral medicines have been quantified using a variety of methods, including UV, capillary electrophoresis, and chromatographic methods such as GC and HPLC, LC-MS, and GC-MS. The authors of this review focus on stability, recommending HPLC/RP-HPLC technologies for the precise and effective development and validation of antiviral medicines such as Zidovudine, [15][16][17][18][19][20] Lamivudine, [20][21][22][23] Nevirapine, [24][25][26][27] Ritonavir, [28][29][30][31] Abacavir, [32][33][34] Efavirenz, [35][36][37][38] Tenofovir, [39][40][41] Fosamprenavir, [42][43][44][45][46] Atazanavir, [47][48] Emtricitabine, 35,35,39,49 Fosamprenavir, [42][43][44][45][46] Tipranavir, [50][51] Darunavir, [52]…”

Section: Various Stability Indicating Methodsmentioning

confidence: 99%

Overview of Forced Degradation Analysis for FDA Approved Antiretroviral agents: A Review

Lamichhane¹,

Das²,

Adhikari³

et al. 2022

J Young Pharm

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Forced degradation and its analysis play a crucial role in the development and production of pharmaceutical products at various stages. Such studies include the assessment of appropriate drug candidates, product development, as well as comparability studies, clarification of probable intermediates and identification of by-products, and the development of stability-indicating technologies. The stability of drugs can be analyzed with Forced degradation study, which gives perspective knowledge of the molecule's stability as well as the degradant that is produced during the drug's shelf life. In this review on stability-indicating methods for FDA approved antiretroviral drugs from such as Zidovudine

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Section: Various Stability Indicating Methodsmentioning

confidence: 99%

Overview of Forced Degradation Analysis for FDA Approved Antiretroviral agents: A Review

Lamichhane¹,

Das²,

Adhikari³

et al. 2022

J Young Pharm

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“…The method detection limit (MDL) is the same as the IDL (0.14 ng/mL) for wastewater analysis, whereas the MDL for surface analysis is 0.28 pg/cm 2 , taking into account the concentration factor of the extraction step and assuming 100% recovery. The detection and quantification limits of this method are ten to a thousand times lower than those reported in the few methodologies found in the literature for the analysis of BICA by liquid chromatography coupled to less expensive detectors [13][14][15][16][17].…”

Section: Linearity and Limits Of Detection And Quantificationmentioning

confidence: 98%

“…As far as it is known, liquid chromatography coupled to less selective detectors (e.g., ultraviolet, photodiode array and fluorescence detectors) have only been applied to the analysis of BICA in pharmaceutical formulations and biological fluids. The reported limits of detection are in the range of 5 and 146 ng/mL, which are relatively high [13][14][15][16][17]. Furthermore, the studies lack a full validation procedure, including the estimation of the global uncertainty associated to the results.…”

Section: Introductionmentioning

confidence: 99%

Multi-Matrix Approach for the Analysis of Bicalutamide Residues in Oncology Centers by HPLC–FLD

et al. 2021

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Cytostatics are toxic pharmaceuticals, whose presence in surfaces puts healthcare workers at risk. These drugs might also end up in hospital effluents (HWW), potentially damaging aquatic ecosystems. Bicalutamide is a cytostatic extensively consumed worldwide, but few analytical methods exist for its quantification and most of them require advanced techniques, such as liquid chromatography mass spectrometry (LC-MS), which are very complex and expensive for large monitoring studies. Therefore, a simple but reliable multi-matrix high performance liquid chromatographic method, with fluorescence detection, was developed and validated to rapidly screen abnormal concentrations of bicalutamide in HWW and relevant contamination levels of bicalutamide in indoor surfaces (>100 pg/cm2), prior to confirmation by LC-MS. The method presents good linearity and relatively low method detection limits (HWW: 0.14 ng/mL; surfaces: 0.28 pg/cm2). Global uncertainty was below 20% for concentrations higher than 25 ng/mL (HWW) and 50 pg/cm2 (surfaces); global uncertainty was little affected by the matrix. Therefore, a multi-matrix assessment could be achieved with this method, thus contributing to a holistic quantification of bicalutamide along the cytostatic circuit. Bicalutamide was not detected in any of the grab samples from a Portuguese hospital, but an enlarged sampling is required to conclude about its occurrence and exposure risks.

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“…The reported analytical techniques were HPTLC, spectroscopic 5 and HPLC. [6][7][8][9][10] Goal of the current research was to progress a precise and specific LC-MS/MS technique for the quantitaation of fosamprenavir in plasma samples and application of method validation as per regulatory guidelines.…”

Section: Fosamprenavir Chemically Designated As {[(2r 3s)-1-[n-(2-met...mentioning

confidence: 99%

LC-ESI-MS/MS Method for the Fosamprenavir Quantification Bioanalytical Method Development and Validation for the Quantification Fosamprenavir in Human Plasma by LC-ESI-MS/MS

Susmitha¹,

Menaka²

2022

Ind. J. Pharm. Edu. Res

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Objectives:The main goal of the current research was to develop a bioanalytical technique for the quantification of fosamprenavir in plasma by LC-ESI-MS/MS. Materials and Methods: Chromatographic elution was attained thru a Zorbax (3.5 µm; 50×4.6 mm) analytical C 18 -column with isocratic system by methanol, 0.1%v/v formic acid and acetonitrile in the ratio of 60:10:30 V/V as mobile phase with flowrate of 0.70 ml/ min. Liquid-liquid extraction was executed for the drug separation with an ethyl acetate solvent. Parent and product ions were monitored at m/z 586.19 /57.0 for Fosamprenavir and 590.0/61.0 for Fosamprenavir-D4 on MRM. Results: Linearity plot of fosamprenavir was rectilinear over the concentration of 4.0-1600.0 ng/ml with correlation coefficient (r 2 ) value of more than 0.99. The developed procedure has fine recovery with percentage recovery findings of HQC, MQC and LQC standards were present between 89.65% to 95.61%. The % RSD findings were < 6.30% for intra-day and inter-day accuracy and precision. Conclusion: Fosamprenavir has more stability for longer time when subjected for different stability environments and the technique was effectively relevant to routine analysis of fosamprenavir in biological matrix.

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Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fosamprenavir Calcium in Pure and Pharmaceutical Dosage Forms

Cited by 9 publications

References 12 publications

Overview of Forced Degradation Analysis for FDA Approved Antiretroviral agents: A Review

Overview of Forced Degradation Analysis for FDA Approved Antiretroviral agents: A Review

Multi-Matrix Approach for the Analysis of Bicalutamide Residues in Oncology Centers by HPLC–FLD

LC-ESI-MS/MS Method for the Fosamprenavir Quantification Bioanalytical Method Development and Validation for the Quantification Fosamprenavir in Human Plasma by LC-ESI-MS/MS

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