RP-HPLC Method Development and Its Validation for Simultaneous Estimation of Alprazolam and Fluoxetine Hydrochloride in Pharmaceutical Dosage Form
 
More details
Hide details
1
Department of Pharmaceutics, B.H.U., Varanasi
2
School of Pharmaceutical Sciences, R.G.P.V., Bhopal
CORRESPONDING AUTHOR
Shubhanjali Shukla   

Department of pharmaceutics, B.H.U., Varanasi
Publish date: 2017-10-08
 
Eurasian J Anal Chem 2010;5(3):239–245
KEYWORDS
ABSTRACT
A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Alprazolam(Alp) and Fluoxetine Hydrochloride(Flx) in tablet dosage form by reverse phase C18 column, Phenomenex (250mm x 4.60mm), Particle Size 5 m.. The sample was analyzed by using Acetonitrile: Water in the ratio of 75:25 (pH adjusted to 2.75 with 0.1% orthophosphoric acid) as a mobile phase at a flow rate of 1.1 ml/min in isocratic mode and detection at 224 nm. Both the drugs were eluted within 5 minutes and give sharp peak with high theoretical plate count and low tailing factor. The retention time for Fluoxetine Hydrochloride and Alprazolam was found to be 2.02 and 3.14 min respectively. The validation was carried according to ICH guidelines. In linearity curve correlation coefficient for Alprazolam and Fluoxetine Hydrochloride was found to be 0.9989 and 0.9994 respectively. The percent recovery was 99.56 for Alprazolam and 99.96 for Fluoxetine Hydrochloride indicating accuracy and reliability of method. So the method can be used for estimation of combination of these drugs in tablet dosage form.
 
REFERENCES (17)
1.
http://medicine complete.com//alprazolam Clark’s analysis of drug and poison .htm.
 
2.
Indian pharmacopoeia (1996) Govt. of India, Ministry of health and family welfare, Delhi 1: 34-35.
 
3.
Perez L. P., Garcia-Montoya E., Orriols A., Minarro M., Tico J.R., Sune-Negre JM, (2004), Development and validation of a new HPLC analytical method for the determination of alprazolam in tablets. J Pharm Biomed Anal 34(5): 979-987.
 
4.
Samanidou V F, Pechlivanidou A P, Papadoyannis I N (2007) “Development of a validated HPLC method for the determination of four 1, 4-benzodiazepines in human biological fluids. J Sep Sci 30(5):679-87.
 
5.
Toshimasa T O, Kumaki Y, Kanbori M, Kato M, Yuji N (2003), “Determination of hypnotic benzodiazepines (alprazolam, estazolam, and midazolam )and their metabolites in rat hair and plasma by reversed phase liquid chromatography with electro spray ionization mass spectrometry. J Pharm Biomed Anal 30: 1773-1787.
 
6.
Hefnawy M. M.(2002) Analysis of certain tranquilizers in biological fluids. J Pharm Biomed Anal 27(5): 661-678.
 
7.
Crouch D.J., Rollins D.E., Canfield D.V., Andrenyak D.M., Schulties J.E.(1999), Quantitation of alprazolam and alpha-hydroxyalprazolam in human plasma using liquid chromatography electrospray ionization MS-MS. J Anal Toxicol 23(6):479-85.
 
8.
Gu J K, Xia R, Zhong D F, Sun L (2002) Identification of estazolam, alprazolam and triazolam in human urine by LC/MS. Yao Xue Xue Bao 37(2): 138-140.
 
9.
Huidobro A L, Ruperez F, Barbas C J (2007) Isolation, identification and determination of major degradation product in alprazolam tablets during their stability assay. J Pharm Biomed Anal 44: 404 – 413.
 
10.
Nudelman N S, Cabrera GC (2002) “Spectrofluorimetric assay for the photo degradation products of alprazolam”, J Pharm Biomed Anal 30(3): 887 – 893.
 
11.
http://medicine complete. com// Fluoxetine Clark’s analysis of drug and poison .htm.
 
12.
Mohamed A E, Mokhtar M M, Fawzy A E (2002) Liquid chromatographic determination of Fluoxetine HCl. J Pharm Biomed Anal 30: 851-856.
 
13.
Nora U, Sergio B, Inigo R A, Alberto G C, Joan S, Ramon J B (2007) Determination of fluoxetine, norfluoxetine and their enantiomers in rat plasma and brain samples by liquid chromatography with fluorescence detection. J Chromatogr Sci B; 852: 519 – 528.
 
14.
Manuela T M, Constantino R D, Teresa G, Jose A M (2000) Determination of the antidepressant fluoxetine in human plasma by LC with UV detection. J Pharm Biomed Anal 23: 989- 996.
 
15.
Raggi M A, Mandrioli R, Casamenti G, Bugamelli F, Volterra V (1998) Determination of fluoxetine and norfluoxetine in human plasma by high-pressure liquid chromatography with fluorescence detection. J Pharm Biomed Anal 18:193 –199.
 
16.
Sabbioni C, Bugamelli F, Varani G, Laura M, Alessandro M, Maria A S, Salvatore F, Maria A R (2004) A rapid HPLC-DAD method for the analysis of fluoxetine and norfluoxetine in plasma from overdose patients. J Pharm Biomed Anal 36: 351 - 356.
 
17.
ICH (Q2B) Validation of analytical procedures methodology, International Conference on Harmonization, Geneva, 1993.
 
eISSN:1306-3057