Stress Degradation Studies And Development Of Stability Indicating Assay Method For Estimation Of Sorafenib In Bulk And Its Formulation
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Abstract
A sensitive high-performance liquid chromatographic (HPLC) method were developed and validated for the estimation of Sorafenib tosylate in bulk and pharmaceutical formulations. The chromatographic separation was achieved by RP- HPLC using a mixture of Acetonitrile: Methanol (45:55) as the mobile phase, a C18 column & at 263 nm with flow rate 1ml/min. The linear and reproducible calibration curve over the range was 2–20 μg/ml. These methods were tested and validated for various parameters according to ICH guidelines. The proposed methods were successfully applied for the determination of Sorafenib tosylate in pharmaceutical formulations. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2%), while being simple, cheap and less time consuming. The method showed adequate precision with a relative standard deviation (RSD) smaller than 3%. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentration used. Degradation studies were carried out under conditions of Alkali Degradation, Acid Degradation, dry heat Degradation, Peroxide Degradation, and UV light and the drug substances were degraded in all conditions. Force degradation studies shows all the degradant peak obtained during degradation were well resolved from main peak of the drugs. The analytical procedure is reliable and offers not only advantages in terms of speed but also met the regulatory requirements for specificity, Linearity, LOD, LOQ, Precision, accuracy
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References
Sethi. P.D., HPLC, Quantitative analysis of pharmaceutical formulation, CBS Publisher and Distributor, New Delhi, preface, 101
Beckett AS., Stenlake JB., “Practical Pharmaceutical chemistry”, fourth edition, volume 2, CBS Publisher and Distributor, New Delhi, 1997; 1-85.
https://en.wikipedia.org/wiki/Sorafenib
M. Sudheer1, A. B. N. Nageswara Rao, D. Hari Hara Theja, M. Siva Prakash, Development of Stability Indicating RP-HPLC Method for Simultaneous Determination of Azithromycin and Ambroxol HCl (SR) in the Tablet Formulation. Der Pharmacia Lettre, 2012, 4 (3):803-810
ICH, Stability Testing of New Drug Substances and Products, International Conference on Harmonization, IFPMA, Geneva, 2003
Indian Pharmacopoeia, Government of india ministry of health & family welfare, published by the Indian Pharmacopoeia commission, Ghaziabad, 2014; vol. III: 2774.
Jayaprakash R, Natesan S. Optimization of stability indicating RP-HPLC method for the estimation of an anti-cancer drug Sorafenib Tosylate in pure and pharmaceutical dosage form. Int. J. Of Pharmacy and Analytical Research, 2017; 6(1): 141-152.
Database of FDA Approval for Sorafenib Tosylate, Compilation prepared by National Cancer Institute, https://www.cancer.gov/aboutcancer/treatment/drugs/fda-sorafenib-tosylate date of access: 18 March 2018.
Database of Pubchem open chemistry, Compilation prepared by U. S. National Library of Medicine, https://pubchem.ncbi.nlm.nih.gov/compound/Sorafe nib_tosylate#section =Top date of access: 18 march 2018.
ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products, International Council for Harmonisation Geneva. 〈http://www.ich.org/products/ guidelines /quality/ article/ quality-guidelines/html), 2003
Heinz WJ, Kahle K, Beyersdorf A, Schirmer D, Lenker U, Keller D, Langmann P, Klinker H. Highperformance liquid chromatographic method for the determination of sorafenib in human serum and peritoneal Xuid. Cancer Chemother Pharmacol, 2011; 68: 239–245.
Kalaichelvi R, Jayachandran E. Quantitative Estimation of Sorafenib Tosylate Its Pure Form and in Its Tablet Formulation by RP-HPLC Method. Journal of Chemistry, 2013: 1-3.
Damle MC*, Kale S. Development and Validation of Stability-Indicating HPTLC Method for Estimation of Sorafenib tosylate. European Journal of Biomedical and Pharmaceutical Sciences, 2017; 4(6): 432-438.
ICH guidelines, Q2 (R1): Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization Geneva. 〈http://www.ich.org/products/ guidelines/quality/article/quality guidelines/html), 2005
Michael W. Dong,” Modern HPLC for practicing scientist” A John Wiley & Sons, Inc., Publication, Page no. 194,217.
Jeffery GH., Basset J., Mendham J., Denney RC., “Vogel’s textbook of quantitative analysis”, 5th Edn., Longman Scientific and Technical, 1999: Page no. 10-11.
Skoog, DA., West DM., Holler FJ., “Analytical chemistry –An Introduction”, 6th Edn., Saunder college publishing, 1994: Page no 3.
Sharma BK., “Instrumental methods of chemical analysis”, 23rd Edn., Goel publishing House, Meerut, 2004: Page no7-8.
Beckett AS., Stenlake JB., “Practical Pharmaceutical chemistry”, 4th Edn, vol 2, CBS Publisher and Distributor, New Delhi, 1997: Page no 1-85.
Christianah MA., Pui-Kai L., “Analytical Profile of Drug Substances” Edi. By Klaus Florey, Page no 124-141.
Beckett, A.H., Stenlake. J.B., “Practical Pharmaceutical chemistry”, 4th Edn., Part –II, CBS Publishers and Distributors, New Delhi, Page no 278-282.
Ahuja S., Scypinski S., “Handbook of modern pharmaceutical analysis”, Vol.3, Academic press,2001: Page no 349.
Christen GD., Analytical Chemistry, fifth ed., John Wiley & Sons, Inc.2001: Page no 505
Illet and Ripper, “Selectivity optimization in HPLC”, In; Brown, R., Phyllis, Eligrushka, Advances in chromatography, 39, Marcel Dekker, Inc.,1998: Page no 264-65.
Sethi PD., PLC-Quantitative analysis of pharmaceutical formulations”, CBS publishers and Distributors, New Delhi, 2001: Page no 11.
Sethi PD., HPLC-Quantitative analysis of pharmaceutical formulations”, CBS publishers and Distributors, New Delhi,200 Page no 1-5.