Validation of a Stability‐Indicating HPLC Method for the Determination of Amiodarone HCl and Its Related Substances in Amiodarone HCl Injection

2004 ◽  
Vol 27 (1) ◽  
pp. 95-111 ◽  
Author(s):  
Matthew J. Christopherson ◽  
Kenton J. Yoder ◽  
R. Brent Miller
Keyword(s):  
Hplc Method ◽  
Stability Indicating ◽  
Related Substances

Preparation and Characterization of Four Major Novel Degradation Products of Pralatrexate Injection and Validation of HPLC-UV Method

2019 ◽  
Vol 15 (7) ◽  
pp. 724-737
Author(s):  
Regella Venkata Rama Prabhakara Sastry ◽  
Chidambaram Subramanian Venkatesan ◽  
Bhetanabhotla Sarveswara Sastry ◽  
Singaram Sathiyanarayanan ◽  
Sanapati Murali
Keyword(s):  
Degradation Products ◽  
Drug Product ◽  
Light Stress ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Liquid Formulation ◽  
Stability Indicating ◽  
Related Substances ◽  
Validation Parameters

Background: Four major degradation products (1-4) of pralatrexate injection were formed under hydrolytic and light stress conditions. The impurities 1 and 2 were the potential photo degradation products and the impurities 3 and 4 were the potential hydrolytic degradation products. Objective: To prepare and characterize the novel degradation impurities 1, 2, 3 and 4 of pralatrexate injection using NMR, HR MS and IR techniques; and to develop and validate stability indicating analytical reverse phase HPLC-UV method for quantitative simultaneous determination of potential degradation impurities, related substances of pralatrexate and pralatrexate active in pralatrexate liquid formulation. Methods: Gradient HPLC-UV method was developed for the quantification of degradation impurities, related substances and pralatrexate in pralatrexate injection. The separation was achieved on C18 column (250 mm X 4.6 mm, 5µm) using a mobile phase composed of sodium dihydrogen phosphate monohydrate in water (pH 3.0; 0.01M) and methanol. The components were monitored by the UVvisible detector at 242 nm with a flow rate of 1.0 mL/min. Results: The method validation parameters such as accuracy, selectivity, linearity, LOD, LOQ, precision, ruggedness and robustness were demonstrated successfully for pralatrexate and its degradation impurities. The stability-indicating capability of the developed HPLC method was demonstrated by adequate separation of all potential pralatrexate related substances from pralatrexate stressed drug product samples. Conclusion: The developed stability indicating HPLC method was found to be suitable for the simultaneous quantitative determination of potential degradation impurities and related substances of pralatrexate and pralatrexate active in pralatrexate liquid formulation.

New Validated Stability-Indicating RP-HPLC Method for The Determination of Docetaxel and Its Related Substances

2019 ◽  
Vol 12 (9) ◽  
pp. 4165
Author(s):  
S. Hemchand ◽  
R. Ravi Chandra Babu ◽  
Mukthinuthalapati Mathrusri Annapurna
Keyword(s):  
Hplc Method ◽  
Stability Indicating ◽  
Related Substances ◽  
Rp Hplc

scholarly journals Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib

2012 ◽  
Vol 2012 ◽  
pp. 1-13 ◽  
Author(s):  
Kasa Srinivasulu ◽  
Mopidevi Narasimha Naidu ◽  
Kadaboina Rajasekhar ◽  
Murki Veerender ◽  
Mulukutla Venkata Suryanarayana
Keyword(s):  
Formic Acid ◽  
Mobile Phase ◽  
Gradient Elution ◽  
Hplc Method ◽  
Forced Degradation ◽  
Balance Study ◽  
Stability Indicating ◽  
Related Substances ◽  
Mass Balance Study

A novel, simple, sensitive, stability indicating HPLC method was developed and validated for quantification of impurities (process related and degradants) and assay determination of bortezomib. Stability indicating power of the method was established by forced degradation experiments and mass balance study. The chromatographic separation was achieved with Waters SymmetryShield RP18 column using gradient elution using the mobile phase-A consists of a mixture of water-acetonitrile-formic acid (715 : 285 : 1, v/v/v) and the mobile phase-B consists a mixture of methanol-water-formic acid (800 : 200 : 1, v/v/v), respectively. The developed method is validated for parameters like precision, accuracy, linearity, LOD, LOQ, and ruggedness. Central composite experimental design (CCD) was applied to check the robustness of the method. The stability tests were also performed on drug substances as per ICH norms.

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