Simple RP-UFLC Method for Analysis of Asenapine Maleate
DOI:
https://doi.org/10.37285/ijpsn.2015.8.2.7Abstract
A stability-indicating reversed phase ultra-fast liquid chromatographic method was developed to determine asenapine maleate (ASN) in pharmaceutical dosage form. A two level factorial design was adopted to improve intermediate precision considering analysts, instruments and number of days as the variables. Chromatographic separation was achieved on Enable-C18G (250× 4.6 mm i.d., 5 μm) column using acetonitrile: 0.01M TBAHS (40:60 v/v) as mobile phase at flow rate of 1.0 ml/min and with PDA detection at 229 nm. Calibration curve was linear in the range of 1.0-200 μg/ml. Values of accuracy were within the acceptance limit with mean percent recoveries between 101.2-101.5%. The percent RSD values were within the acceptance limit for repeatability and intermediate precision. Limit of detection and limit of quantitation were found to be 0.25 and 0.5 μg/ml, respectively. Besides, applicability of analytical method showed high specificity for ASN and its degradation products formed during forced degradation studies. The developed UFLC method was found to be specific, selective, accurate, precise and robust for determination of ASN in bulk and pharmaceutical dosage form.
Downloads
Metrics
Keywords:
Asenapine, ultra-fast liquid chromatography, factorial design, forced degradation.
Downloads
Published
How to Cite
Issue
Section
References
Aarelly K, Thimmraju MK and Nerella R (2012). Quantitative determination of asenapine in both bulk and Formulations using Neutralization Titrations.J Appl Pharm Sci. 2(8): 141-145.
Aneesh TP and Rajasekaran A (2012). Stress Degradation Studies and Development and Validation of RP-HPLC method for the Estimation of Asenapine Maleate. Int J Pharmacy Pharm Sci. 4(4): 448-451.
Chhalotiya UK, Bhatt KK, Shah DA and Patel JR (2012). Stability-Indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic agent Asenapine in Bulk and in Pharmaceutical Formulation. Sci Pharm 80(2): 407-417.
Gandhimathi R, Vijayaraj S and Jyothirmaie MP (2012). Method Development and Validation of UV-Spectroscopic Method for Estimation of Asenapine maleate in Bulk and Tablet Formulation. Int J Med Chem Anal 2(2): 85-90.
Halima OA, Aneesh TP, Ghosh R and Thomas NR (2012). Development and Validation of UV spectrophotometric method for the Estimation of Asenapine Maleate in Bulk and Pharmaceutical Formulation. Der Pharma Chemica. 4(2): 644-649.
Heyden YV, Jimidar M, Hund E, Niemeijer N, Peeters R, Smeyers-Verbeke J, Massart DL and Hooghmartens J (1999). Determi-nation of System Suitability Limits with Robustness test. J Chromatogr. A 845: 145-154.
Hibbert DB (2012). Experimental Design in Chromatography: a tutorial review. J Chromatogr B. 910: 02-13.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005). Guideline on Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonized Tripartite Guideline, Geneva, Switzerland.
Mrudulesh Y, Ravi sankar P, Devadasu CH and Babu PS (2013). Development of a Validated UV spectrophotometric Method for the Quantitative Estimation of Asenapine maleate in Bulk Drug. J. Chem Pharm Sci. 6(4): 227-230.
O Neil MJ, editor (2006). The Merck Index, 14th ed., NJ: USA, Merck Research Laboratories 832.
Parthasarathi TR, Srinivas TS, Vanitha sri M, Ram SS, Basha MM and Rajesh P (2012). Quantitative Determination of Asenapine Maleate using Reverse Phase-high Performance Liquid Chromatography. Int J Pharm Bio Sci. 3(4): 360-366.
Patteet L, Maudens KE, Sabbe B, Morrens M, De Doncker M and Neels H (2014). High throughput Identification and Qualification of 16 Antipsychotics and 8 Major Metabolites in Serum using Ultra-high performance Liquid chromatography-Tandem Mass spectrometry. Clin Chim Acta. 429: 51-58.
Reddy AVB, Venugopal N and Madhavi G (2013). Simultaneous Determination of Asenapine and Valproic acid in human plasma using LC-MS/MS: application of the method to support pharmacokinetic study. J Pharm Anal. 3(6): 394-401.
Stoner SC and Pace HA (212). Asenapine: A Clinical Review of a Second-generation Antipsychotic.Clin Ther. 34: 1023-1040.
Tarazi FI and Shahid M (2009). Asenapine maleate: a new drug for the Treatment of Schizophrenia and Bipolar mania. Drugs Today (Barc.). 45(12): 865-876.
Yanamadala G, Gupta VR, Srikumar PP, Rusyendra GV and Lavanya N (2013). Development and Validation of RP-HPLC Method for the Estimation of Asenapine Maleate in Bulk and in Pharmaceutical Dosage Forms. Asian J Pharm Anal Med Chem. 1(2): 132-139.
