Stress degradation studies on tadalafil and development of a validated stability-indicating LC assay for bulk drug and pharmaceutical dosage form

Chromatographia

Volumn 67, Issue 1-2, 2008, Pages 183-188

  Rao, D V Subba ^a   Radhakrishnanand, P ^a   Himabindu, V ^b  

^a UNITED STATES PHARMACOPEIA   (United States)

^b JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY   (India)

Author keywords

Column liquid chromatography; Stability indicating assay; Tadalafil

Indexed keywords

ACETONITRILE; AMMONIUM SULFATE; PHOSPHATE BUFFERED SALINE; TADALAFIL;

ACCURACY; ALKALINITY; ARTICLE; DRUG DEGRADATION; DRUG DETERMINATION; DRUG DOSAGE FORM; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROLYSIS; LIQUID CHROMATOGRAPHY; OXIDATIVE STRESS; PHOTOLYSIS; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVERSED PHASE LIQUID CHROMATOGRAPHY; SENSITIVITY AND SPECIFICITY; TEMPERATURE STRESS; VALIDATION PROCESS;

EID: 38048999202     PISSN: 00095893     EISSN: 16121112     Source Type: Journal    
DOI: 10.1365/s10337-007-0478-1     Document Type: Article

References (13)

1. International Conference on Harmonization (2003) Stability testing of new drug substances and products Q1A (R2). International Conference on Harmonization, IFPMA, Geneva
2. Singh S, Bakshi M (2000) Pharm Tech Online 24:1-14
3. International Conference on Harmonization (1996) Photo stability testing of new drug substances and productsQ1B. International Conference on Harmonization, IFPMA, Geneva
4. Bakshi M, Singh S (2002) J Pharm Biomed Anal 28:1011-1040
5. Singh S, Singh B, Bahuguna R, Wadhwa L, Saxena R (2006) J Pharm Biomed Anal 41:1037-1040
6. Carstensen JT, Rhodes CT (eds) (2000) Drug stability principles and practices, 3rd edn
7. http://www.cialis.com
8. Aboul-Enein HY, Ali I (2005) Talanta 65:276
9. Shakya AK, Abu-awwad ANA, Arafat TA, Melhim M (2007) J Chromatogr B 852:403-408
10. Cheng CL, Chou CH (2005) J Chromatogr B 822:278
11. Ali I, Aboul-Enein HY (2004) Chromatographia 60:187-191. doi: 10.1365/s10337-004-0366-x
12. Rodríguez Flores J, Berzas Nevado JJ, Castaňeda Peňalvo G, Mora Diez N (2004) J Chromatogr B 811:231
13. Ramakrishna NVS, Vishwottam KN, Puran S, Koteshwara M, Manoj S, Santosh M, Chidambara J, Wishu S, Sumatha B (2004) J Chromatogr B 809:243