Validation of Stability-Indicating Reverse Phase HPLC Method for the Determination of Related Substances in Dapagliflozin Drug Substance

Goutam Sen; K. Raghu Babu; N. Annapurna; N.A. Vekariya; Vundavilli Jagadeesh Kumar; K.S.R. Pavan Kumar; Hemant Kumar Sharma

doi:10.46624/ajptr.2018.v8.i5.026

Validation of Stability-Indicating Reverse Phase HPLC Method for the Determination of Related Substances in Dapagliflozin Drug Substance

American Journal of PharmTech Research ◽

10.46624/ajptr.2018.v8.i5.026 ◽

2018 ◽

Vol 8 (5) ◽

pp. 322-336

Author(s):

Goutam Sen ◽

K. Raghu Babu ◽

N. Annapurna ◽

N.A. Vekariya ◽

Vundavilli Jagadeesh Kumar ◽

...

Keyword(s):

Hplc Method ◽

Drug Substance ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Stability Indicating ◽

Related Substances

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Development and Validation of Reverse Phase HPLC Method for Enantiomer Excess Determination of Tenofovir Disoproxil Fumarate drug Substance

Asian Journal of Research in Chemistry ◽

10.5958/0974-4150.2020.00064.4 ◽

2020 ◽

Vol 13 (5) ◽

pp. 334-340

Author(s):

Ch. Ramesh ◽

D. Rama Devi ◽

MNB. Srinivas ◽

Nagaraju Rajana ◽

S. Radha Krishna ◽

...

Keyword(s):

Tenofovir Disoproxil Fumarate ◽

Hplc Method ◽

Drug Substance ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Enantiomer Excess ◽

Development And Validation

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A novel reverse phase stability indicating RP-UPLC method for the quantitative determination of fifteen related substances in Ranolazine drug substance and drug product

Talanta ◽

10.1016/j.talanta.2012.03.067 ◽

2012 ◽

Vol 97 ◽

pp. 563-573 ◽

Cited By ~ 3

Author(s):

Vakamulla Malati ◽

Anumala Raghupati Reddy ◽

K. Mukkanti ◽

M.V. Suryanarayana

Keyword(s):

Quantitative Determination ◽

Phase Stability ◽

Drug Product ◽

Drug Substance ◽

Reverse Phase ◽

Stability Indicating ◽

Related Substances

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Development and validation of a stability-indicating RP-HPLC method for the identification, determination of related substances and assay of dimethyl fumarate in drug substance

Annales Pharmaceutiques Françaises ◽

10.1016/j.pharma.2020.10.002 ◽

2020 ◽

Author(s):

S. Kommareddy ◽

R.S. Nigam ◽

S. Kumar

Keyword(s):

Dimethyl Fumarate ◽

Hplc Method ◽

Drug Substance ◽

Stability Indicating ◽

Related Substances ◽

Rp Hplc ◽

Development And Validation

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Development and validation of a novel stability-indicating HPLC method for the quantitative determination of eleven related substances in ezetimibe drug substance and drug product

Talanta ◽

10.1016/j.talanta.2015.02.039 ◽

2015 ◽

Vol 139 ◽

pp. 67-74 ◽

Cited By ~ 8

Author(s):

Zhiqiang Luo ◽

Zhongqing Deng ◽

Yang Liu ◽

Guopeng Wang ◽

Wenning Yang ◽

...

Keyword(s):

Quantitative Determination ◽

Drug Product ◽

Hplc Method ◽

Drug Substance ◽

Stability Indicating ◽

Related Substances ◽

Development And Validation

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Stability-Indicating Reverse Phase HPLC Method for the Determination of Cefazolin

Tropical Journal of Pharmaceutical Research ◽

10.4314/tjpr.v9i1.52034 ◽

2010 ◽

Vol 9 (1) ◽

Cited By ~ 6

Author(s):

N Lalitha ◽

P Sanjay ◽

M.G Vyshak ◽

U Kadri

Keyword(s):

Hplc Method ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Stability Indicating

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DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPLC METHOD FOR THE DETERMINATION OF CROMOLYN SODIUM AND ITS RELATED SUBSTANCES IN CROMOLYN SODIUM DRUG SUBSTANCE AND CROMOLYN SODIUM INHALATION SOLUTION, 1.0%

Journal of Liquid Chromatography &amp Related Technologies ◽

10.1081/jlc-100101795 ◽

1999 ◽

Vol 22 (14) ◽

pp. 2187-2209 ◽

Cited By ~ 9

Author(s):

R. Mansfield ◽

J. Huang ◽

S. Thatcher ◽

R. B. Miller ◽

C. W. Davis

Keyword(s):

Hplc Method ◽

Cromolyn Sodium ◽

Drug Substance ◽

Stability Indicating ◽

Related Substances ◽

Development And Validation

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Development and validation of a reverse-phase HPLC method for analysis of efavirenz and its related substances in the drug substance and in a capsule formulation

Journal of Pharmaceutical and Biomedical Analysis ◽

10.1016/s0731-7085(00)00495-7 ◽

2001 ◽

Vol 25 (2) ◽

pp. 267-284 ◽

Cited By ~ 14

Author(s):

Eda Ross Montgomery ◽

Amy L Edmanson ◽

Stacy C Cook ◽

Paul K Hovsepian

Keyword(s):

Hplc Method ◽

Drug Substance ◽

Capsule Formulation ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Related Substances ◽

Development And Validation

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Development and Validation of a Stability-indicating RP-HPLC Method for the Simultaneous Determination of Telmisartan and its Related Substances in Telmisartan Bulk Drug Substance

Analytical Chemistry Letters ◽

10.1080/22297928.2020.1850348 ◽

2020 ◽

Vol 10 (5) ◽

pp. 577-589

Author(s):

Jayram V. Gholave ◽

Nayan S. Gadhari ◽

Suyog S. Patil ◽

Sharad S. Upadyay ◽

Vishwanath R. Patil ◽

...

Keyword(s):

Simultaneous Determination ◽

Hplc Method ◽

Drug Substance ◽

Stability Indicating ◽

Related Substances ◽

Rp Hplc ◽

Bulk Drug ◽

Development And Validation

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Development of a stability– indicating HPLC method for simultaneous determination of ten related substances in vonoprazan fumarate drug substance

Journal of Pharmaceutical and Biomedical Analysis ◽

10.1016/j.jpba.2017.11.011 ◽

2018 ◽

Vol 149 ◽

pp. 133-142 ◽

Cited By ~ 5

Author(s):

Zhiqiang Luo ◽

Aoxue Liu ◽

Yang Liu ◽

Guopeng Wang ◽

Xinjing Chen ◽

...

Keyword(s):

Simultaneous Determination ◽

Hplc Method ◽

Drug Substance ◽

Stability Indicating ◽

Related Substances

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A Validated Reverse-Phase HPLC Method for Quantitative Determination of Ganoderic Acids A and B in Cultivated Strains of Ganoderma spp. (Agaricomycetes) Indigenous to India

International Journal of Medicinal Mushrooms ◽

10.1615/intjmedmushrooms.v19.i5.70 ◽

2017 ◽

Vol 19 (5) ◽

pp. 457-465 ◽

Cited By ~ 4

Author(s):

M. Ramakrishna ◽

D. Rajesh Babu ◽

S. S. Veena ◽

Meera Pandey ◽

Nageswara Rao

Keyword(s):

Quantitative Determination ◽

Hplc Method ◽

Reverse Phase Hplc ◽

Reverse Phase ◽

Ganoderic Acids

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