Volume : 11, Issue : 10, October – 2024
Title:
QUANTITATIVE ESTIMATION OF HYOSCINE BUTYL BROMIDE AND PARACETAMOL IN TABLET DOSAGE FORMS BY RP-HPLC METHOD
Authors :
S.Shyamala*, Mrs.R.Madhulika,R.Mounika,Dr.K.Shravankumar
Abstract :
A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Hyoscine butyl bromide and Paracetamol in its pure form as well as in combined marketed formulation. Chromatography was carried out on a X bridge C18 (4.6mm×150mm) 5µm particle size column using a mixture of ACN: Methanol (70:30% v/v) as the mobile phase at a flow rate of 1.2ml/min, the detection was carried out at 260nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Hyoscine butyl bromide and 10-30mg/ml of Paracetamol. The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Keywords: Hyoscine butyl bromide and Paracetamol, RP-HPLC, Validation, Accuracy, Precision.
Cite This Article:
Please cite this article in press S.Shyamala et al., Quantitative Estimation Of Hyoscine Butyl Bromide And Paracetamol In Tablet Dosage Forms By RP-HPLC Method..,Indo Am. J. P. Sci, 2024; 11 (10).
Number of Downloads : 10
References:
1. Dr. Kealey and P.J Haines, Analytical Chemistry, 1stedition, Bios Publisher, (2002), PP 1-7.
2. A.BraithWait and F.J.Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
3. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition, Academic press, (1997), PP 24-37.
4. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
5. Chromatography, (online). URL:http://en.wikipedia.org/wiki/Chromatography.
6. Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Ed. England, John Wiley & Sons Ltd, (2004), PP 7-8.
7. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
8. D. H. Shewiy, E. Kaale, P. G. Risha, B. Dejaegher, J. S. Verbeke, Y. V. Heyden, Journal Pharmaceut. Biomed. Anal, 66, 2012, 11-23.
9. M. D. Rockville, General Tests, Chapter 621 – Chromatography System Suitability, United States Pharmacopeial Convention (USP), USP 31, 2009.
10. FDA Guidance for Industry-Analytical Procedures and Method Validation, Chemistry, Manufacturing, and Controls Documentation, Centre for Drug Evaluation and Research (CDER) and Centre for Biologics Evaluation and Research (CBER), 2000.
11. Korany MA, Mahgoub H, Ossama TF, Hadir MM. Application of artificial neural networks for response surface modelling in HPLC method development. J Adv Res, 3, 2012, 53-63.
12. Swartz ME, Jone MD, Fowler P, Andrew MA. Automated HPLC method development and transfer. Lc Gc N. Am, 75, 2002, 49-50.
13. Snyder LR, Kirkland JJ, Glajach JL. X. In Practical HPLC Methods Development. John Wiley, New York, 295, 1997, 643-712.
14. Swartz M, Murphy MB. New Fronties in Chromatography. Am Lab, 37, 2005, 22-27.
15. Dolan JW. Peak tailing and resolution. Lc Gc N. Am, 20, 2002, 430-436.