K Anandakumar, D Jothieswari, R Subathrai, K Varatharajan, G Sivanseyal
K Anandakumar*, D Jothieswari, R Subathrai, K Varatharajan and G Sivanseyal
Department of Pharmaceutical Analysis, Adhiparasakthi College of Pharmacy, Melmaruvathur – 603 319, Tamil Nadu, India.
Volume - 3,
Issue - 1,
Year - 2010
A simple, precise, rapid and accurate RP-HPLC method was developed and validated for the estimation of Balsalazide in bulk and in capsule dosage forms. Isocratic elution at a flow rate of 0.7 ml/min was employed on a Phenomenax Luna C18 column (150´4.6mm; 5m) at an ambient temperature. The mobile phase consists of Acetonitrile: Methanol: Triethylamine buffer (40:30:30% v/v). The effluents were monitored at 254nm and 20ml of sample was injected. Nifedipine was used as an internal standard (IS). The retention times for Balsalazide and IS were 3.42 and 5.07 min, respectively. The method obeys Beer's law in the concentration range of 10-50 mg/ml. The respective linear regression equation being Y= 0.03727x + (-0.0084). The percentage assay of BSZ was 99.61% ± 0.106. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of BSZ in bulk drug and in its pharmaceutical dosage form.
Cite this article:
K Anandakumar, D Jothieswari, R Subathrai, K Varatharajan, G Sivanseyal.Development and Validation of RP–HPLC Method for the Estimation of Balsalazide in Pure and in Pharmaceutical Dosage forms.Research J. Pharm. and Tech. 3(1): Jan. - Mar. 2010; Page 136-140.
K Anandakumar, D Jothieswari, R Subathrai, K Varatharajan, G Sivanseyal.Development and Validation of RP–HPLC Method for the Estimation of Balsalazide in Pure and in Pharmaceutical Dosage forms.Research J. Pharm. and Tech. 3(1): Jan. - Mar. 2010; Page 136-140. Available on: https://rjptonline.org/AbstractView.aspx?PID=2010-3-1-69
Anonymous. CIMS-94, CMP Media India
Private Limited, Bangalore, July-2006, 13 and 42.
Giaffer MH, Holdsworth CD and
Lennard Jones JE. Improved maintenance of re emission in ulcerative colitis by
Balsalazide 4 gm/ day compared with 2 gm/ day. Aliment Pharmacology
Therapeutics, 2000, 479-485.
Green JRB, Lobo AJ and Holdsworth
CD. Balsalazide is more effective and better tolerated than in the treatment of
acute ulcerative colitis. Gastroenterology, 2000, 114.
Muijser RB. A review of its
therapeutic use in mild to moderate ulcerative colitis. Drugs, 2002, 62.
Tripathi KD. Essentials of Medical
Pharmacology. 5th edn., Jaypee Brothers Medical Publishers (P) Ltd.,
2004, 263, and 620-621.
Sandborn WJ, Hanauer SB and Buch A.
Comparative pharmacokinetics of equimolar doses of 5-aminosalicylate
administered as oral mesalamine (Asacol) and Balsalazide: a randomized,
single-dose, crossover study in healthy volunteers 1. Alimentary Pharmacology
and Therapeutics, 1998, 1089-1098.
Hussain FN, Ajjan RA and Riley SA.
Dose loading with delayed-release Balsalazide and 5-ASA: A study of tissue drug
concentrations and standard pharmacokinetic parameters. British Journal of
Clinical Pharmacology, 2000, 4, April, 323.
Anonymous. Code Q2A and Q2B- Text
on Validation of analytical procedures, Step 3 and 4, Consensus Guideline, ICH
Harmonised Triplicate Guideline. 1994.