Development and validation of HPLC method for simultaneous determination of Ketotifen Fumarate and Salbutamol Sulfate in bulk and tablets dosage forms

Author:

Yousuf Muhammad1,Ahmad Mahmood2,Usman Muhammad3,Naeem Muhammad4,Ali Khan Barkat5,Khalid Khan Muhammad5

Affiliation:

1. Institute of Pharmaceutical Sciences, Peoples University of Medical and Health Sciences for Women, Nawabshah, Sindh, Pakistan

2. Director ORIC, University of Central Punjab, Lahore, Pakistan

3. Faculty of Pharmacy University of Sargodha, Punjab, Pakistan

4. Department of Pharmacy, Shah Abdul Latif University Khairpur, Sindh, Pakistan

5. Drug Designand Cosmetics Lab (DDCL), Gomal Centre of Pharmaceutical Sciences, Gomal University, D.I.Khan, Pakistan

Abstract

The aim of the study was to develop and validate a new, rapid, sensitive, simple, accurate and reproducible HPLC method for simultaneous determination of ketotifen fumarate and salbutamol sulfate. Simultaneous HPLC method was developed using RP-C18 stainless steel analytical column 4.6×150 mm C18.Acetonitrile and phosphate buffer pH 4 (30 : 70) were used as mobile phase and wavelength was adjusted to 276 nm for detection of drugs. Developed method was validated for its specificity, accuracy, precision, linearity and robustness. Method was also applied to quantify drugs in commercial tablets. Chromatogram obtained by newly developed method for simultaneous determination of two anti-asthmatic drugs, having well distinguished peaks for both drugs. Retention time of ketotifen fumarate and salbutamol sulfate were 2.69 minutes and 9.47 minutes respectively. Total run time for both anti-asthmatic drugs was 12 minutes. Limit of quantification for ketotifen fumarate and salbutamol sulfate was 1 ng/ml and 1.50 ng/ml respectively. Limit of detection of ketotifen fumarate and salbutamol sulfate was 3.03 and 4.54 respectively. A simple, easy, precise and new method was developed for simultaneous quantification of frequently used anti-asthmatic drugs. Developed method may prove effective and beneficial in determination of ketotifen fumarate and salbutamol sulfate in bulk and other pharmaceutical dosage forms.

Publisher

IOS Press

Subject

Materials Chemistry,Inorganic Chemistry,Organic Chemistry

Reference13 articles.

1. Transdermal patch for ketotifen fumarate (ktf) as asthmatic drug;Patel;Int J Pharm Tech Res,2009

2. The mast cell stabilizer ketotifen fumarate lessens contracture severity and myofibroblast hyperplasia: a study of a rabbit model of posttraumatic joint contractures;Monument;J Bone Joint Surg,2010

3. Sweetman S.C. and Britain P. Bronchodilators and Anti-asthma drugs. In: Sweetman SC, editor. Martindale: the complete drug reference. London: Pharmaceutical Press, 36th ed. (2009), 757–786.

4. Spectrophotometric estimation of ketotifen and salbutamol by validated analytical method from tablet dosage form;Singh;J Chem Pharm Res,2013

5. Optimization and validation of HPLC method for the analysis of ketotifen fumarate in a pharmaceutical formulation;Semreen;Bull Pharm Sci Assiut University,2005

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