Gradient RP-HPLC method for the determination of potential impurities in atazanavir sulfate

Chitturi, Sreenivasa Rao; Somannavar, Y. S.; Peruri, Badarinadh Gupta; Nallapati, Sreenivas; Sharma, Hemant; Budidet, Shankar Reddy; Handa, V. K.; Vurimindi, Hima Bindu

doi:10.1016/j.jpba.2011.01.002

Cited by 22 publications

(7 citation statements)

References 24 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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“…Shell particles are a relatively recent trend in chromatographic separation, but several pharmaceutical-bioanalytical [105][106][107][108][109][110][111][112][113][114][115][116][117][118], food analytical [119][120][121][122][123][124][125][126][127][128][129], environmental [130][131][132][133][134] and multidimensional [135][136][137] separations can be found in the literature. Very recently, new commercially available wide-pore stationary phases demonstrate exceptional efficiency for protein separations [138][139][140].…”

Section: Superficially Porous Particlesmentioning

confidence: 99%

Evolution and Current Trends in Liquid and Supercritical Fluid Chromatography

Fekete¹,

Perrenoud²,

Guillarme

2014

CCHG

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Abstract:The current trend in high performance liquid chromatography (HPLC) tends toward the achievement of higher separation efficiency and shorter analysis time. Indeed, better performance in LC has become increasingly important in recent years mainly driven by the challenges of either analyzing more complex samples or increasing the numbers of samples per time unit. In the recent development of particle technology, the use of fully porous sub-2 m particles and sub-3 m shell particles have received considerable attention. Beside packed columns, the new generation of silica-based monolithic columns also offers very high separation power. However, to take full advantage of these innovative phases, the chromatographic system has also to be drastically optimized in terms of upper pressure limit and system volume.This revolution in column technology now spreads and covers several modes of liquid chromatography such as reversedphase liquid chromatography (RPLC), hydrophilic interaction liquid chromatography (HILIC), or even supercritical fluid chromatography (SFC). The HILIC and SFC, which can be considered as alternative modes of chromatography, could also be useful to extend the applicability of chromatography towards the analysis of very hydrophilic and lipophilic compounds, respectively.The present review gives an insight about the theory behind the success of current column technology and presents a summary of latest applications, using various modes of one-dimensional chromatography (RPLC, HILIC, SFC). This paper also shows that theoretically expected column efficiency could sometimes be compromised in practical work especially in the case of narrow bore columns.

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“…Several research papers have been reported in the literature for the determination of Atazanavir sulfate stability indicative methods by HPLC [17][18][19][20][21][22][23]. No methodology was available for Acid impurity and Keto impurity at individuals and also for the combination of four genotoxic impurities as well.…”

Section: Introductionmentioning

confidence: 99%

A Selective and Sensitive Lc-MS/MS Method for Quantification of Four Potential Genotoxic Impurities in Atazanavir Sulfate Drug Substance in Trace Level

Jyothi

Muvvala

2021

Int J App Pharm

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Objective: The main objective of current research work is to develop and validate a rapid, sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the trace analysis of four potential genotoxic impurities in Atazanavir Sulfate drug substance. Methods: LC-MS/MS analysis of four potential genotoxic impurities was done on Acquity UPLC CSH C18 (100 mm × 2.1 mm, 1.7 μm) column. In this method, mobile phase A (10 mM ammonium acetate) mobile phase B (methanol: acetonitrile (90:10, v/v) with gradient run with the flow rate of 0.2 ml/min. The method was developed with the short run time of 13 min. Triple quadrupole mass detector coupled with positive electrospray ionization was used for the quantification of genotoxic impurities in multiple reaction monitoring (MRM) mode. Results: The method was linear in the range of 0.3 ppm to 4.5 ppm for BOC Hydrazine Acid impurity, BOC Epoxide and Keto impurity with a correlation coefficient not less than 0.9994. The accuracy of the method was in the range of 99.26% to 105.71% for all four potential genotoxic impurities (PGIs). No impurities were identified in the Atazanavir Sulfate active pharmaceutical ingredient sample. Conclusion: The proposed method is specific, linear, precise, accurate, robust and stable for the quantification of the four genotoxic impurities at very low levels.

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Gradient RP-HPLC method for the determination of potential impurities in atazanavir sulfate

Cited by 22 publications

References 24 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

Evolution and Current Trends in Liquid and Supercritical Fluid Chromatography

A Selective and Sensitive Lc-MS/MS Method for Quantification of Four Potential Genotoxic Impurities in Atazanavir Sulfate Drug Substance in Trace Level

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