METHOD DEVELOPMENT AND VALIDATION OF VALACYCLOVIR HYDROCHLORIDE AND RITONAVIR IN TABLET DOSAGE FORM USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
DOI:
https://doi.org/10.11113/jt.v76.3093Keywords:
Valacyclovir HCl, Tablet, HPLC, ritonavir, validationAbstract
Our main objective is to develop an accurate and precise RP-HPLC method for the simultaneous determination of Valacyclovir HCl and Ritonavir in tablet dosage form. An Agilent TC-C18 (2) column is used for the Separation of drugs by a mobile phase consisting of methanol, acetonitrile and water mixture in the ratio of 35:41.5:23.5v/v. The flow rate maintained was 1.3 mL/min and the wavelength used for detection was 222 nm. The linearity was observed in the range of 12.5-125µg/ml for Valacyclovir HCl (VC) and Ritonavir (RT) with a correlation coefficient of 0.9987 and 0.9981 respectively. The mean percentage recoveries for 80%, 100% and 120% accuracy were found to be 101.7%±2.09, 100%±2.49 and 101.5%±1.61 respectively for VC. The mean percentage recoveries for 80%, 100% and 120% accuracy were found to be 104.3%±0.99, 100%±1.77and 99.0%±1.22 respectively for RT. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation. The developed method can be utilized in the analysis of VC and RT tablets.
References
N. S. Umapathy, V. Ganapathy, and M. E. Ganapathy. 2004. Transport of Amino Acid Esters and the Amino-acid-Based Prodrugvalganciclovir by the Amino Acid Transporter ATB. Pharm. Res. 21: 1303-1310.
S. C. Sweetman. 2011. Martindale: The Complete Drug Reference. 34th edition. Pharmaceutical Press, London. 653, 656.
A. C. Moffat, M. D. Osselton, B. Widdop, and J. Watts. 2004. Clarke’s Analysis of Drugs and Poisons. 3rd Edition. Volume 2: 1538, 1690.
M. Sugumaran, and D. Jothieswari. 2010. Development and Validation of Spectroscopic Method for Estimation of Valacyclovir in Tablet Dosage Form. Orient. J. Chem. 26(1): 163-165.
J. Sudhakar Reddy, Md. S. Maqsood Ahmed, I. E. Chakravarth, and K. Prabhavathi. 2011. Spectrophotometric Estimation of Valacyclovir in Pharmaceutical Preparations. Journal Of Chemical And Pharmaceutical Research. 3(4): 773-776.
G. Srihari, N. Rami Reddy, K. Nagaraja Setty, and I. E. Chakravarthi. 2013. Spectrophotometric Determination Of Valacyclovir In Pharmaceutical Formulations. Chem. Sci. Trans. 2(1): 61-64.
B. Jahnavi, and G. Ashok. 2013. Method Development And Validation Of Valacyclovir Hydrochloride Assay by RP-HPLC In Pharmaceutical Dosage Form. International Journal of Advanced Research in Pharmaceutical and Biosciences. 3: 33-41.
M. Sugumaran, V. Bharathi, R. Hemachander, and M. Lakshmi. 2011. RP-HPLC Method for the Determination of Valacyclovir in Bulk and Pharmaceutical Formulation. Der Pharma Chemica. 3(4): 190-194.
S. Yasmeen, A. Nanda Kishore, and P. Safiakhanam. 2013. Development and Validation of Stability Indicating Rp-Hplc Method for Estimation of Valacyclovir in Pharmaceutical Dosage Forms. International Journal Of Pharmaceutical And Clinical Research. 5: 7-12.
Sk. Rasool, D. V. Naik, D. Prasad Babu, and Buchi N. Nalluri. 2012. RP-HPLC Method for the Estimation of Valacyclovir in Bulk and Pharmaceutical Formulations. International Journal of Pharmacy and Pharmaceutical Sciences. 4(1): 214-218.
P.N. Rao, K. Rajeshwari, R. Jayathirtharao, and J. V. L. N. Vseshagirirao. 2006. RP-HPLC Estimation of Valacyclovir in Tablets. Asian Journal of Chemistry. 18(4): 2552-2556.
Y. Sultana, N. K. A. Agarwal, and P. S. Khanam. 2013. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Valacyclovir in Pharmaceutical Dosage Forms. International Journal of Pharmaceutical and Clinical Research. 5: 7–12.
J. J. Sasanya, Abd-Alla, A. M. M. Parker, and A. G. Cannavan. 2010. Analysis of the Antiviral Drugs Acyclovir and Valacyclovir-Hydrochloride Iin Tsetse Flies (Glossina Pallidipes) Using LC-MSMS. J Chromatogr B Analyt Technol Biomed Life Sci. 878(26): 2384-90.
K. Seetaramaiah, A. Anton Smith, K. Ramyateja, G. Alagumanivasagam, and R. Manavalan. 2012. Spectrophotometric Determination of Ritonavir in Bulk and Pharmaceutical Formulation. Scientific Reviews And Chemical Communications. 2: 1-6.
A. Behera, M. Swapan Kumar, S.S. Chandra, M. Amit Kumar, and A. Gowrisankar. 2011. Method Development, Validation and Stability Study of Ritonavir in Bulk and Pharmaceutical Dosage Form. Spectrophotometric Method. 2: 161-167.
V. P. Nagulwar, and K. P. Bhusari. 2012. Development Of UV Spectrophotometric First Order Derivative Method For The Simultaneous Estimation Of Ritonavir and Lopinavir in Combined Tablet Dosage Form. International Journal of Pharmaceutical Sciences and Research. 3: 2317-2320.
L. Carolina, M. B. Ana, and E. F. Pedro. 2009. UV-Derivative Spectrophotometric Determination of Ritonavir Capsules and Comparison With LC Method. Anal. Lett. 42: 1900-1910.
C. L. Dias, A. M. Bergold, and P. E. Froehlich. 2009. UV-Derivative Spectrophotometric Determination of Ritonavir Capsules and Comparison with LC Method. Analytical Letters. 42: 1900-1910.
M. P. Gadhvi, A. Bhandari, B. N. Suhagia, and U. H. Desai. 2013. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Atazanavir and Ritonavir In Their Combined Tablet Dosage Form. Research Journal of Pharmacy and Technology. 6(2): 200-203.
M. Jagadeeswaran, N. Gopal, K. Pavan Kumar, and T. Sivakumar. 2012. Quantitative Estimation Of Lopinavir And Ritonavir In Tablet Dosage Forms By RP-HPLC Method. American Journal of Pharmtech Research. 2(2): 576-583.
K. Gowthami, Ghousia Fatima, Maimona Farheen, Fatima Yasmeen, Sana Afreen, Madurai Sailaja, Shaik Saidabi, and Shaik Moqeemoddi. 2012. Sensitive Analytical Method Development and Validation of Ritonavir Bulk Drugs by RP-HPLC. Journal Of Scientific Research In Pharmacy. 1(1): 20-22.
H. A. Mohammad, A. G. Azza, A. S. Rasha, and K. A. Heba. 2012. Validated Stability-Indicating HPLC and HPTLC Methods for the Determination of Ritonavir in Bulk Powder Andin Capsules. Journal of Food and Drug Analysis. 20: 963–973.
Downloads
Published
Issue
Section
License
Copyright of articles that appear in Jurnal Teknologi belongs exclusively to Penerbit Universiti Teknologi Malaysia (Penerbit UTM Press). This copyright covers the rights to reproduce the article, including reprints, electronic reproductions, or any other reproductions of similar nature.
