Reverse Phase Ultrafast Liquid Chromatography Method for Simultaneous Estimation of Citicoline Sodium and Piracetam in Tablets
DOI:
https://doi.org/10.37285/ijpsn.2013.6.1.5Abstract
A simple, precise and accurate RP-UFLC method was developed for simultaneous determination of citicoline sodium and piracetam in tablets. Separation was carried on an Enable C18G column (250 mm × 4.6 mm i.d., 5 μm) using methanol: water (10 mM TEA) (75:25, v/v) as mobile phase at flow rate of 1 ml/min in isocratic mode. The PDA detection wavelength was 225 nm. The retention time of citicoline sodium and piracetam were 1.985 and 3.007 min, respectively. The method was validated for linearity, specificity, precision, accuracy and robustness as per ICH guidelines. The method was linear in the concentration range of 1.0 –250 µg/ml with correlation coefficients of 0.999 for both the drugs. The LOD and LOQ for citicoline sodium were 0.25 µg/ml and 0.81 µg/ml, respectively, and for piracetam 0.28 µg/ml and 0.93 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 100.24-101.09% and 100.08-101.05% for citicoline sodium and piracetam, respectively. The R.S.D. values for intraday, interday and system precision were found to be less than 2%. The method was applied successfully for simultaneous estimation of citicoline sodium and piracetam in combined tablet formulation.
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Keywords:
Citicoline, piracetam, reverse phase-ultra fast liquid chromatography, triethylamine
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Aniruddha TJ, Pillai S, Indira Devi B, Sampath S and Chandramouli BA (2009). Role of citicoline in the management of mild head injury. Indian J Neurotrauma 6: 49-52.
Arayne MS, Sultana N, Siddiqui FA, Mirza AZ, Qureshi F and Zuberi MH (2010). Simultaneous determination of piracetam and its four impurities by RP-HPLC with UV detection. J Chrom Sci 48: 589-594.
Babu G, Prasad K, Kolla T, Vijayabaskaran M and Latha ST (2011). Method development and validation of RP-HPLC for simultaneous estimation of citicoline and piracetam in tablet dosage form. Int J PharmTech Res 3: 1311-1313.
Bhowmick AA, Khandelwal KR, Mhaske DV and Khadke S (2010). Analytical method development and validation for piracetam as bulk and in pharmaceutical formulation. Int J PharmTech Res 2: 201-204.
Bindaiya, SK,Sahu, K,Bhaisare, M,Karthikeyan C,Moorthy NSHN,Mehta FF and Trivedi P (2011). Development and validation of a RP-HPLC method for determination of citicoline monosodium in human plasma. Lat Am J Pharm 30: 794-798.
Chaudhry HR, Najam N, De Mahieu C, Razza A and Ahmad N (1992). Clinical use of piracetam in epileptic patients. Curr Ther Res Clin E 52: 355-360.
Chen K, Liu X, Wei C, Yuan G, Zhang R, Li R,Wang B and Guo R (2011). Determination of Uridine in human plasma by HPLC and its application in citicoline sodium pharmacokinetics and bioequivalence studies. J Bioequiv Availab 3: 72-76.
Cuticapean A and Imre S (2007). New validated method for piracetam HPLC determination in human plasma. J Biochem Bioph Meth 69: 273-281.
El-Saharty YS(2008). Simultaneous determination of piracetam and vincamine by spectrophotometric and high-performance liquid chromatographic methods. J AOAC Int 91: 311-321.
Flicker L and Grimley Evans G (2001). Piracetam for dementia or cognitive impairment. Cochrane Database Syst Rev 2: CD001011.
Ganduri RB, Peddareddigari JR, Dasari NR and Saiempu RK (2010). Stability indicating LC method for the determination of citicoline sodium in injection formulation. Int J PharmTech Res 2: 427-433.
Garcia-Cobos R, Frank-Garcia A, Gutierrez-Fernandez M and Diez-Tejedor E (2010). Citicoline use in cognitive decline:vascular and degenerative. J Neurol Sci 299: 188-192.
Gouliaev AH and Senning A (1994). Piracetam and other structurally related nootropics. Brain Rese Rev 19: 180-222.
Helfgott E, Rudel RG and Kairam R (1986). The effect of piracetam on short- and long-term verbal retrieval in dyslexic boys. Int J Psychophysiol 4: 53-61.
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.
Karamancheva I and Staneva T (2000). Determination of possible impurities in piracetam using FTIR spectroscopy. J Pharm Biomed Anal 21: 1161-1169.
Lestari AD, Prasetyo AT, Palupi T, Umayah E, Yuwono M and Director GI (2005). HPLC determination of piracetam in tablets-validation of the method. J Liq Chromatogr R T 28: 1407-1416.
Malipatil SM, Patil SK, Deepti M and Jahan K (2010). New spectrophotometric methods for the determination of citicoline in pharmaceutical formulations. International Journal of Pharmaceutical Research and Development 2: 27-30.
Metwally FH, Elzeany BA and Darwish HW (2005). New methods for determination of cinnarizine in mixture with piracetam by spectrodensitometry, spectrophotometry, and liquid chromatography. J AOAC Int 88: 1666-1676.
Patel JA, Panigrahi B, Patel CN and Badamanaban R (2011). Stress degradation studies on citicoline sodium and development of a validated stability-indicating HPLC assay. Chron Young Sci 2: 150-154.
Parisi V, Manni G, Colacino G and Bucci MG (1999). Cytidine-5´-diphosphocholine (citicoline) improves retinal and cortical responses in patients with glaucoma. Ophthalmology 106: 1126-1134.
Prajapati MG, Parmar RR, Patel VM and Shah DA (2012). Development and validation of analytical method for citicoline and piracetam in pharmaceutical dosage form by UV spectrophotometric method. International Journal of Institutional Pharmacy and Life Sciences 2: 438-446.
Raveendra babu G, Sri madhu SM, Rao MP, Ajay babu CH, Reddy PJ and Nagaraju D (2010). A validated ,specific stability-indicating RP-LC method for citicoline and its related substances in oral drops. Int J Pharm Tech 2: 652-667.
Sachan N, Chandra P, Yadav M , Pal D and Ghosh AK (2011). Rapid analytical procedure for citicoline in bulk and pharmaceutical dosage form by UV spectrophotometer. J Appl Pharm Sci 1: 191-193.
Surani S, Kimbahune R, Kabra P and Urmila GH (2010). Spectrophotometric determination of citicoline sodium in pure form and pharmaceutical formulation. Der Pharmacia Lettre 2: 353-357.
Sweetman SC (2009). Martindale-The Complete Drug Reference, 36th ed., London: UK,. Pharmaceutical Press 2283.
Sweetman SC (2009). Martindale-The Complete Drug Reference, 36th ed., London: UK, Pharmaceutical Press, 368.
Uttarwar SO, Jadhav RT and Bonde CG (2010). Stability indicating LC method for citicoline sustained release tablet. Int J PharmTech Res 2: 2482-2486.
Wang X, Zhu J, Xu R, Yang X, Wu H, Lin D, Ye F and Hu L (2010). Determination of piracetam in rat plasma by LC-MS/MS and its application to pharmacokinetics. Biomed Chromatogr 24: 1108-1112.
Zhao-hua Z, Yu-ying C and Ying-xiang D (2003). HPLC measurement of related substances and citicoline content in citicoline sodium and NaCl injection. Chin J New Drugs 12: 1022-1024.
