Determination of duloxetine hydrochloride in the presence of process and degradation impurities by a validated stability-indicating RP-LC method

Journal of Pharmaceutical and Biomedical Analysis

Volumn 51, Issue 4, 2010, Pages 994-997

  Raman, N V V S S ^a   Harikrishna, K A ^a   Prasad, A V S S ^a   Reddy, K Ratnakar ^a   Ramakrishna, K ^b  

^a Hetero Drugs Limited   (India)

^b GITAM UNIVERSITY   (India)

Author keywords

Degradants; Determination; Duloxetine; Stability indicating method; Validation

Indexed keywords

ACETONITRILE; DULOXETINE; METHANOL; PHOSPHORIC ACID; PHOSPHORUS DERIVATIVE; SOLVENT; TRIETHYLAMINE;

ARTICLE; DRUG DEGRADATION; DRUG DETERMINATION; DRUG IMPURITY; HYDROLYSIS; OXIDATIVE STRESS; PH; PRIORITY JOURNAL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; VALIDATION PROCESS;

ANTIDEPRESSIVE AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, REVERSE-PHASE; DRUG CONTAMINATION; DRUG STABILITY; HYDROGEN-ION CONCENTRATION; HYDROLYSIS; OXIDATION-REDUCTION; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL; THIOPHENES;

EID: 72449140145     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2009.10.025     Document Type: Article

References (6)

1. International Conference on Harmonisation Guideline on Stability Testing of New Drug Substances and Products, Q1A (R2), 2003.
2. International Conference on Harmonisation Guideline on Photostability Testing of New Drug Substances and Products, Q1B, 1996.
3. International Conference on Harmonisation Guideline on Impurities in New Drug Products, Q3B (R2), 2006.
4. The Merck Index, Merck & Co., Inc., Whitehouse Station, NJ, USA, 2006, 14:587.
5. Srinivasulu P., Srinivas K.S., Reddy R.S., Mukkanti K., and Buchireddy R. Pharmazie 64 (2009) 10-13
6. International Conference on Harmonisation Guideline on Validation of Analytical Procedures: Text and Methodology, Q2 (R1), 2005.