Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Buffer-Free High Performance Liquid Chromatography Method for the Determination of Theophylline in Pharmaceutical Dosage Forms

Mahibub M Kanakal^1,3 , Aman Shah Abdul Majid³, Munavvar Zubaid A Sattar², Noor Shahida Ajmi⁴, Amin Malik Shah Abdul Majid²

¹Department of Pharmaceutics, Faculty of Pharmacy, UiTM-PP, Bertam Campus, Kepala Batas,13200 P.Pinang; ²School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11400 P.Pinang; ³Cluster of Integrative Medicine, Advanced Medical and Dental Institute, Universiti Sains Malaysia; ⁴Department of Pharmacy, Allianze University College of Medical Sciences (AUCMS), 13200, Kepala Batas,13200 P.Pinang, Malaysia.

For correspondence:- Mahibub Kanakal Email: mehboobct@gmail.com Tel:0060194516823

Received: 15 January 2013 Accepted: 30 November 2013 Published: 25 January 2014

Citation: Kanakal MM, Majid AS, Sattar MZ, Ajmi NS, Majid AM. Buffer-Free High Performance Liquid Chromatography Method for the Determination of Theophylline in Pharmaceutical Dosage Forms. Trop J Pharm Res 2014; 13(1):149-153 doi: 10.4314/tjpr.v13i1.21

© 2014 The authors.
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Abstract

Purpose: To develop and validate a simple, economical and reproducible high performance liquid chromatographic (HPLC) method for the determination of theophylline in pharmaceutical dosage forms.

Method: Caffeine was used as the internal standard and reversed phase C-18 column was used to elute the drug and standard. The mobile phase was prepared by mixing water:acetonitrile:methanol at the ratio of 90:03:07 and the pH set at 4.6. Flow rate and ultraviolet (UV) detector were set at 1.0 mLmin^-1 and 271 nm, respectively. The method was validated for linearity, recovery, accuracy, precision, specificity, and also for inter-day stability under laboratory conditions.

Results: Retention time was 5.5 min. The limits of detection and quantification were 12.5 ngmL^-1 and 100 ngmL^-1, respectively_. Recovery accuracy (%) for different concentrations ranged from 100.05 to 102.43; regression coefficient (R²) of 0.994; precision RSD < 2.0, and negligible interference from common excipients.

Conclusion: The method is simple, rapid, highly specific and suitable for the determination of theophylline. Absence of buffer and use of small quantity of organic solvents increase the life span of the column and reduce the cost of routine analysis of theophylline in industry.

Keywords: Buffer-free, High performance liquid chromatography, Theophylline, Dosage form