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Babu, B.
- Development and Validation of an Analytical Liquid Chromatography-Tandem Mass Spectroscopy Method for the Estimation Febuxostat in Pharmaceutical Formulation
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Authors
Lingamallu Venkata Sai Krishna
1,
S. T. Narenderan
1,
Ramshankar Nayak
1,
S. N. Meyyanathan
1,
B. Babu
1,
M. Kalaivani
2
Affiliations
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, IN
2 Indian Pharmacopoeia Commission, New Delhi, IN
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, IN
2 Indian Pharmacopoeia Commission, New Delhi, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 5 (2019), Pagination: 2137-2140Abstract
A rapid LC-MS/MS method has been developed and validated for the quantitative determination of Febuxostat from the commercially available formulations. The separation was achieved using Zorbax SB C18 column (4.6 × 50 mm, 5 μm) as a stationary phase and the mobile phase consists of (10 mM) Ammonium formate (pH4.0): methanol (10:90 v/v) with a flow of 0.6 mL/min. Detection was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode with proton adducts at m/z 316.95→260.95 to monitor Febuxostat within a run time of 2 min. The linearity of the method was found over a concentration range of 4 to 55 ng/mL with a regression analysis of 0.997. The percentage recovery of the present method was found to be 97.16 to 99.46%. The LC-MS/MS method was validated as per ICH guidelines. The developed method can be successfully applied for the estimation of Febuxostat in the commercial formulation and in bulk drug.Keywords
Febuxostat, Formulation, LC-MS/MS, Validation, Electrospray Ionization.
References
- Drug details, URL: https://pubchem.ncbi.nlm.nih.gov/compound/Febuxostat#section=Top
- Rajyalakshmi Ch., Benjamin T., Ram Babu C. Development and Validation of Zero and First Order Derivative UV-Spectrophotometric Method for Determination of Febuxostat in Bulk and in Formulation. Research. J. Pharm. and Tech. 2013; 6(2): 208-211.
- J. M. Derasari, V. B. Patel. Spectrophotometric Determination of Febuxostat and Diclofenac Potassium in Their Combined Dosage Form by Simultaneous Equation and First Order Derivative Methods. Asian J. Research Chem. 2013; 6(10): Page 968-972.
- D. M. Darandale, K.B. Erande, S.R. Tambe, R.S. Bhamber. Development and Validation of RP-HPLC Method for the Determination of Febuxostat in Bulk and Pharmaceutical Dosage Form. Asian J. Research Chem. 2017; 10(6):713-718.
- Muvvala SS, Ratnakaram VN, Nadendla RR. Validated RP-HPLC method for the estimation of febuxostat in bulk drugs. Int J pharmTech Res. 2012; 4(4): 1358-1366.
- Kumar RS, Ravikumar BVV, Anjaya Kumar P. A RP-HPLC method development and validation for estimation of febuxostat bulk and pharmaceutical dosage forms. Int Res J Pharm. 2012; 3(11): 205-208.
- Chandu BR, Kanala K, Hwisa NT, Katakam P, Khagga M. Bio-equivalance and pharmacokinetic study of febuxostat in human plasma by using LC-MS/MS with liquid liquid extraction method. Spinger plus, 2013; 2(194): 1-10.
- Pal N, Rao AS, Kumar PR. New method development and validation for the determination of febuxostat in human plasma by liquid chromatography –mass spectrometry. Int J Pharm Pharm Sci. 2016; 8(9): 61-70.
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- ICH validation, URL:https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
- A Validated Chiral HPLC Method for the Enantiomeric Separation of Mefloquine
Abstract Views :154 |
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Authors
Affiliations
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, IN
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 5 (2019), Pagination: 2304-2308Abstract
A validated direct chiral HPLC method was developed for the separation of enantiomers of Mefloquine. The separation was achieved using chiral PAK IG-3 (250 x 4.6 mm) 3μm column. The mobile phase was composed of 10 mM ammonium acetate and methanol in the ratio of 30:70, v/v. The flow rate of the mobile phase was set at 0.7 ml/min. The detection wavelength was set at 284 nm with column temperature maintained at 25°C. The retention time of both (+) and (-) enantiomers was found to be 4.59 min and 6.47 min, respectively under a runtime of 10 min. The method was validated as per ICH guidelines. The method was found to be linear over a concentration range of 20 – 120 μg/ml and 15 – 105 μg/ml for (+) and (-) Mefloquine enantiomers, respectively. The chiral assay of Mefloquine in a pharmaceutical formulation was performed and the recoveries ranged from 99.3 to 99.9 %. The detection limit for the (+) and (-) enantiomers was found to be 5.5 μg/ml and 5μg/ml, respectively.Keywords
Mefloquine, Enantiomers, HPLC, Validation, ICH.References
- Saravanan J, Suneetha V. Asymmetric synthesis of chiral alcohols for API production using microorganisms - A mini review. Research Journal of Pharmacy and Technology. 2017; 10 (6): 1881 – 1885.
- Mukherjee A and Bera A. Importance of chirality and chiral chromatography in pharmaceutical industry : a detailed study. Journal of current chemical and pharmaceutical sciences. 2012;2 (4): 334-346.
- Ates H, Younes A A, Mangelings D, Heyden YV. Enantioselectivity of polysaccharide-based chiral selectors in polar organic solvents chromatography: Implementation of chlorinated selectors in a separation strategy. Journal of Pharmaceutical and Biomedical Analysis. 2013; 74: 1– 13.
- Liu Y, Tian A, Wang X, Qi J, Wang F, Ma Y, Ito Y, Wei Y. Fabrication of chiral amino acid ionic liquid modified magnetic multifunctional nanospheres for centrifugal chiral chromatography separation of racemates. Journal of Chromatography A. 2015; 1400: 40–46.
- Kalyankar TM, Kakde RB. Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Artesunate and Mefloquine in Pharmaceutical Preparations. Research J. Pharm. and Tech. 2011; 4: 1563-6.
- Syeda Kulsum, Padmalatha M, Eippa Kranthi Kumar, Madireddy Sruthi, Vidyasagar G. Artesunate, Mefloquine, RP-HPLC and validation. Research J. Pharm. and Tech. 2011; 4: 1567-9.
- Kalyankar TM and Kakde RB. Reversed-phase liquid chromatographic method for simultaneous determination of artesunate and mefloquine in pharmaceutical preparations. Research Journal of Pharmacy and Technology. 2011; 4(10): 1563-1566.
- Geditz MCK, Lindner W, Lammerhofer M, Heinkele G, Kerb R, Ramharter M, Schwab M, Hofmann U. Simultaneous quantification of mefloquine (+) - and (−) - enantiomers and the carboxy metabolite in dried blood spots by liquid chromatography/tandem mass spectrometry. Journal of Chromatography B. 2014; 968: 32 – 39.
- ICH, Q2B, Hamonised Tripartite Guideline, Validation of Analytical Procedure: Methodology, IFPMA, in: Proceedings of the International Conference on Harmonization, Geneva, March 1996.
- A Sensitive Liquid Chromatography-tandem Mass Spectrometry Method for the Estimation of Cilostazol in Bulk and in a Pharmaceutical Formulation
Abstract Views :156 |
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Authors
Affiliations
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, IN
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 6 (2019), Pagination: 2781-2783Abstract
The present study reports on a liquid chromatography-tandem mass spectroscopy method for the analysis of Cilostazol drug substance in its formulation. The materials utilize a Zorbax SB C18 analytical column with electrospray ionization and a triple quadrupole mass detector in multiple reaction monitoring (MRM) mode, resulting in a short analysis of 1.5 min runtime and the analyte elute at 0.76 min. Change from SIM to MRM mode resulted in increased sensitivity and low quantitation limit which in turn produces a detection limit of 1 ng/ml. The obtained method was validated in a range of 5-100 ng/ml with a correlation coefficient of 0.9991. The percentage recovery of the present method was found to be in the range of 94% to 100%. The developed method was validated as per the ICH guidelines.Keywords
Cilostazol, LC-MS/MS Method, Electrospray Ionization, MRM.References
- Medicine library. Available from: URL: https://medlineplus.gov/druginfo/meds/a601038.html.
- Alhamide Hoballah SA. Spectrophotometric methods for determination of cilostazol in pure and dosage forms. Int J Res Pharm Chem. 2015; 5(1): 17-26.
- Lesrari AD, Palupi T, Oktarina B, Yuwono M, Indrayanto G. HPLC determination of Cilostazol in tablets, and its validation. J Liquid Chromatogr Related Tech. 2014; 27(16): 2603-2612
- Damor D, Mittal K, Patel B, Mashru R. Method development and validation of simultaneous estimation of cilostazol and telmisartan. Res Rev: J Pharm Ana. 2015; 4(3): 41-48.
- Mohammed E. Abdel-Hamid, Leyla H. Sharaf, Oludotun A. Phillips, Elijah O. Kehinde. A Validated LC-MS/MS Method for the Determination of Tamsulosin Hydrochloride in Six Brands; Applications to Content Uniformity and Dissolution Studies. Research J. Pharm. and Tech. 2011; 4(12): 1885-1890.
- Mohammed Abdel-Hamid, Leyla H. Sharaf. Use of Stable Labeled Internal Standards LC-MS/MS Method for the Detection and Confirmation of Inherited Metabolic Diseases in Sick Infants. Research J. Pharm. and Tech. 2012; 5(6): 768-774.
- Surendran Vijayaraj, Anoop Singh, Kokilam Perumal Sampathkumar. Pharmacokinetic Study of Oxime Prodrug of Gliclazide by LC-MS/MS Method in Rabbit Plasma. Asian J. Research Chem. 2015; 8(5): 351-357.
- ICH, Q3B validation of analytical procedures: methodology, International Conference on Harmonization, November 1996. Available from: URL: https://www.fda.gov/downloads/drugs/guidances/ucm073384.pdf.