Validation and Quantification of Theophylline and Salbutamol using Ion Pair Liquid Chromatography
Salbutamol and theophylline are administered in combination orally to provide the sinergistic effect of drugs. The aim of this study is to develop and to validate ion pair liquid chromatography to determine both drugs in pharmaceutical dosage form, especialy in syrup dosage form. Separation of drugs was performed with Spherisorb C-18 column (250 x 4.6 mm; 10 um). The mobile phase used is the mixture of acetic acid 1% : methanol (60 : 40 v/v) which contain 3.5 mM sodium-1-octanesulphonate, as ion pairing reagent. The mobile phase was delivered isocratically with flow rate of 1 mL/min. UV detection was set at wavelength of 277 nm. The developed method was validated in terms of linearity, precision, accuracy, selectivity, and sensitivity. The precision of the method was evaluated using repeatability assay having relative standard deviation (RSD) values of 0.41–0.70 % for theophylline and 0.08 – 0.24 % for salbutamol. The recovery percentages are in the range of 98.28–101.02% (theophylline) and 100.71–101.60% for salbutamol. The developed method meets the validation requirement for analysis of salbutamol and theophylline simultaneously in syrup dosage form. Furthermore, the method also provides acceptable result for syrup and tablet dosage forms containing Salbutamol and theophylline only, and tablet containing the combination of Salbutamol and theophylline.
Keywords: teophyllin, salbutamol, HPLC, sodium-1-octanesulphonate, validation.
Ahuja, S., & Dong, M. W. (2005). Handbook of Pharmaceutical Analysis by HPLC. Volume 6. New York, Elsevier Academic Press. p. 35.
Anonymous (2005). The Merck Index, 14th Ed., Merck Research Laboratories, Merck & Co, Inc, White house station, NJ, USA.
Anonymous (2005). The Pharmacopoeia of The Peoples Republic of China, People’s Medical Publishing House, 2005.
Basu, M., & Pathak, B. (1990). Estimation of salbutamol sulphate in pharmaceutical formulations. Indian Drugs, 28, 109–110.
Bhatia, N.M., Jain, D.K., & Trivedi, P. (1998). Simultaneous analysis of salbutamol sulfate and bromhexine hydrochloride from solid dosage form using multiwavelength UV-spectrophotometry. Indian Drugs, 35, 566-569.
Ghulam, M., Mahmood, A., Muhammad, A.M., & Muhammad, W.A. (2009). A new reverse phase HPLC method with fluorescent detection for the determination of salbutamol sulfate in human plasma. Bulletin of Chemical Society of Ethiopia,. 23, 1-8.
Gonzalez, A.G., & Herrador, M.A. (2007). A Practical Guide to Analytical Method Validation, Including Measurement Uncertainty and Accuracy Profiles. Trends in Analytical Chemistry, 26 (3), 227-238.
Habib, I.H.I., Hassouna, M.E.M., & Zaki, G.A. (2005). Simultaneous spectrophotometric determination of salbutamol and bromhexin in tablets. Farmaco. 60: 249–254.
Hiral, D.N., Rajeesree, M.C., & Alpesh, P.K. (2010). Thin Layer Chromatographic Methode for the Determination of Ternary Mixture Containing Salbutamol Sulphat, Ambroxol Hydrochloride and Theophylline. International Journal of Pharmaceutical Sciences, 2(1), 390-394.
International Conference on Harmonization, (2002). Guidance on analytical method validation, International convention on quality for the pharmaceutical industry. Toronto, Canada.
Kazakevich, Y.V., & LoBrutto, R. (2007). HPLC for Pharmaceutical Scientist, John Wiley & Sons p. 471-481.
Marcia, S.B., Marcia, C.V., Heloisa, P., Rodolfo, O., & Jose, N.R. (2002). Simultaneous determination of caffeine, theobromine, and theophylline by high performance liquid chromatography. Journal of Chromatraphy Science, 40, 45-48.
Miller J.N., & Miller, J.C. (2005). Statistics and Chemometrics for Analytical Chemistry. 5th Edition, Pearson Education Ltd., Edinburgh, UK.
Mirfazaelian, A., Goudarzi, M., Tabatabaiefar, M., & Mahmoudian, M. (2002). A Quantitative Thin Layer Chromatography Method for Determination of Theophylline in Plasma. Journal of Pharmacy and Pharmaceutical Sciences, 5(2), 131-134.
Mishra, A.K., Kumar, M., Mishra, A., Verma, A., & Chattopadhyay, P. (2010). Validated UV Spectroscopic Method for Estimation of Salbutamol from Tablet Formulation. Scholars Research Library, 2(3), 207-211.
Murthy, N.S., & Hiremath, S.R. (2001). Formulation and Evaluation of Controlled release transdermal Patches of Theophylline – Salbutamol Sulphate. Journal of Asthma, Allergy and Immunology, 2(1), 1-9.
Nagraju, R., & Kaza, R. (2009). Formulation and evaluation of bilayer sustained released tablets of salbutamol and theophylline. International Journal of Pharmaceutical Sciences and Nanotechnology, 2(3), 638-646.
Nikola, L., Dragica, Z., Olgica, S. S., & Igor, K. (2003). Development and validation of the HPLC method for the determination of theophylline serum concentration. Bulletin Chemistry and Technology Macedonia, 22, 97-104.
Nirogi, R.V., Kandikere, V.N., Shukla, M., Mudigonda, K., & Ajjala, D.R. (2007). A simple and rapid HPLC/UV method for the simultaneous quantification of theophylline and etofylline in human plasma. Journal of Chromatography B, 848, 271-276.
Pai, P.N.S., Rao, G.K., Murthy, M.S., Agarwal, A., & Puranik, S. (2009). Simultaneous determination of salbutamol sulphate and bromhexine hydrochloride in tablets by reverse phase liquid chromatography. Indian Journal of Pharmaceutical Sciences, 71, 53–55.
Ramakrishna, V.S.N., Vishwottam, N.K., Manoj, S., Koteshwara, M., & Devender, R.A. (2007). A simple and rapid HPLC/UV method for the simultaneous quantification of theophylline and etofylline in human plasma. Journal of Chromatography B, 848, 271-276.
Satinsky, D., Karlicek, R., & Svaboda, A. (2002). Using on-line solid phase extraction for flow injection spectrophotometric determination of salbutamol. Analytica Chimica Acta,. 455, 103-109.
Snyder, L. R., Kirkland, J. J., & Dolan, J. W. (2010). Introduction to Modern Liquid Chromatography. Third Edition. John Wiley & Sons Inc. Publication, New York, USA.
The United State Phamacopoeia (2009). United State Pharmacopoieal Convention, 32th Ed., Rockvilie, USA.
- There are currently no refbacks.
Copyright (c) 2017 INDONESIAN JOURNAL OF PHARMACY
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
Indonesian J Pharm indexed by:View My Stats