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Development and validation of q-absorbance ratio method for simultaneous estimation of arterolane maleate and piperaquine phosphate in pharmaceutical dosage form
Corresponding Author(s) : Seju D Patel
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 5 No. 2 (2017): 2017 Volume 5- Issue -2
Abstract
New Spectrophotometric Q-Absorbance Ratio method has been developed for the simultaneous estimation of Arterolane maleate and Piperaquine phosphate in tablet dosage form. UV spectrophotometric method, methanol was used as a solvent.
Objective
To develop simple, accurate, linearity, precision and reproducible UV Spectroscopic method for Arterolane maleate and Piperaquine phosphate in routine analysis.
Method
Aliquots of stock solution were further diluted with methanol to get working solution of 2.5-8.75?g/ml for Arterolane maleate and 12.5-43.5 ?g/ml for Piperaquine phosphate working standards were scanned between 200 - 400 nm which shows the maximum absorbance at 276nm.
Results
The Iso -absorptive point was found to be 242 nm. Calibration curve were linear over a concentration range of 2.5-8.75 ?g/ml for Arterolane maleate and 12.5- 43.5 ?g/ml for Piperaquine phosphate. Accuracy of method was determined through recovery studies which were found 99.36%-101.22% for Arterolane maleate and 99.46%- 100.80% for Piperaquine phosphate. Method was found to be reproducible with relative standard deviation for intra- day and inter-day precision to be < 1.5%.
Conclusion
This method was found to be simple, Accurate, precise and reproducible. The proposed UV method can be applicable for the simultaneous estimation of both the drugs in tablet dosage form.
Keywords
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Yuxiang, Dong, Wittlin, Sergio: The Structure- Activity Relationship of the Antimalarial Ozonide Arterolane (OZ277). J Med Chem 53, 2010, 481-491.
[2]. Valecha N: Arterolane maleate plus Piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: A comparative, multicenter, randomized clinical trial. Clin Infect Dis 55, 2012, 663-671
Seju D P et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-5(2) 2017 [648-656]
656
[3]. US Pharmacopoeia, 34 NF 29. The United State Pharmacopoeia Convention Rockville, sep2014 https://mc.usp.org/monograph/piperaquine-phosphate
[4]. Indian Pharmacopoeia, 6th Edn: ministry of health and Family welfare, Indian pharmacopeia commission, Ghaziabad. India 2014, 1084.
[5]. Central Drugs Standard Control Organization. List of Drug Approved For Marketing in India 2011. http://www.cdsco.nic.in/NEW%20DRUG%20UPDATE.DOC
[6]. Tarning J, Singtoroj T, Anneberg Ashton AM and White NJ: Development and validation of an automated solid phase extraction and liquid chromatographic method for the determination of in urine. Journal of Pharmacy Biomed Analysis 1(11), 2006, 213-218.
[7]. Te-Yu Hung, Devis TEM and Ilett KF: Measurement of piperaquine in plasma by liquid chromatography with ultraviolet absorbance detection 1(2), 2003, 93-101.
[8]. Wahajuddin, Raju KS and Teneja I: Bioanalysis of antimalarials using liquid chromatography. TrAC Trends in Analysis Chemistry 42, 2013, 186-204.
[9]. Amin NC, Blanchin MD, Ake M and Fabre H: Capillary electrophorosis methods for the analysis of antimalarials. Journal of chromatoghrphy Analysis 1276, 2013, 1-11.
[10]. Lindegardh N, Anneberg A, White NJ and Day NJ: Development and validation of a liquid chromatographic-tandem mass spectrometric method for determination of Piperaquine in plasma: Stable isotope labeled internal standard does not always compensate for matrix effects. Journal of chromatography B 1(2), 2008, 227-236.
[11]. Hodem EM, Zanolari B, Mercier T, Biollaz J, Keiser J and Decosterd LA: A single LC-tandem mass spectrometry method for the simultaneous determination of 14 antimalarial drugs and their metabolites in human plasma. Journal of chromatography B 10(1), 2009, 867-886.
[12]. Lindegardh N, Tarning J, Toi PV,Hie TT, Farrar J, Singhasivanon P, White NJ, Aston M and Day NP: Quantification of artemisinin in human plasma using liquid chromatography coupled to tandem mass spectrometry. Journal of Pharm biomed analysis 49(3), 2009, 768-773.
[13]. Kirchhorfer C, Keiser J and Huwyler J: Development and validation of a liquid chromatography/ mass spectroscopy method for pharmacokinetic studies of OZ78, a fascocidal drug candidate. Journal of Chromatography B 878(28), 2010, 2770-2774.
References
[2]. Valecha N: Arterolane maleate plus Piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: A comparative, multicenter, randomized clinical trial. Clin Infect Dis 55, 2012, 663-671
Seju D P et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-5(2) 2017 [648-656]
656
[3]. US Pharmacopoeia, 34 NF 29. The United State Pharmacopoeia Convention Rockville, sep2014 https://mc.usp.org/monograph/piperaquine-phosphate
[4]. Indian Pharmacopoeia, 6th Edn: ministry of health and Family welfare, Indian pharmacopeia commission, Ghaziabad. India 2014, 1084.
[5]. Central Drugs Standard Control Organization. List of Drug Approved For Marketing in India 2011. http://www.cdsco.nic.in/NEW%20DRUG%20UPDATE.DOC
[6]. Tarning J, Singtoroj T, Anneberg Ashton AM and White NJ: Development and validation of an automated solid phase extraction and liquid chromatographic method for the determination of in urine. Journal of Pharmacy Biomed Analysis 1(11), 2006, 213-218.
[7]. Te-Yu Hung, Devis TEM and Ilett KF: Measurement of piperaquine in plasma by liquid chromatography with ultraviolet absorbance detection 1(2), 2003, 93-101.
[8]. Wahajuddin, Raju KS and Teneja I: Bioanalysis of antimalarials using liquid chromatography. TrAC Trends in Analysis Chemistry 42, 2013, 186-204.
[9]. Amin NC, Blanchin MD, Ake M and Fabre H: Capillary electrophorosis methods for the analysis of antimalarials. Journal of chromatoghrphy Analysis 1276, 2013, 1-11.
[10]. Lindegardh N, Anneberg A, White NJ and Day NJ: Development and validation of a liquid chromatographic-tandem mass spectrometric method for determination of Piperaquine in plasma: Stable isotope labeled internal standard does not always compensate for matrix effects. Journal of chromatography B 1(2), 2008, 227-236.
[11]. Hodem EM, Zanolari B, Mercier T, Biollaz J, Keiser J and Decosterd LA: A single LC-tandem mass spectrometry method for the simultaneous determination of 14 antimalarial drugs and their metabolites in human plasma. Journal of chromatography B 10(1), 2009, 867-886.
[12]. Lindegardh N, Tarning J, Toi PV,Hie TT, Farrar J, Singhasivanon P, White NJ, Aston M and Day NP: Quantification of artemisinin in human plasma using liquid chromatography coupled to tandem mass spectrometry. Journal of Pharm biomed analysis 49(3), 2009, 768-773.
[13]. Kirchhorfer C, Keiser J and Huwyler J: Development and validation of a liquid chromatography/ mass spectroscopy method for pharmacokinetic studies of OZ78, a fascocidal drug candidate. Journal of Chromatography B 878(28), 2010, 2770-2774.