Development and validation of valganciclovir hydrochloride in bulk and pharmaceutical dosage form by HPTLC method
Keywords:Valganciclovir Hydrochloride, HPTLC, Validation, ICH, Tablet Dosage Form.
A simple, rapid and accurate High performance thin layer chromatography is described for the Development and validation of HPTLC method for Valganciclovir Hydrochloride in bulk and Pharmaceutical dosage form. The separation is carried out on Merck TLC aluminum sheets of silica gel 60 F254 using Chloroform: Methanol: Ammonia (6.5:3.4:0.1v/v) mobile phase. Quantification was done by Densitometric scanning at 254nm. The linearity was found to be the range of 100-500ng/spot for Valganciclovir hydrochloride with the correlation coefficient of 0.9993. The regression equation was found to be Y=10.168x-94.8. The Rf value of Valganciclovir hydrochloride was found to be 0.74. The LOD and LOQ were found to 9.19 and 27.87 respectively. Average recovery was found to be 99.66% which show that the method was free from interference from excipients present in the formulation. Simultaneously the Percentage relative standard deviation was well within the range of 2%. The above method was validated according to the ICH guidelines. The established method enabled accurate, precise and applied to the analysis of Valganciclovir hydrochloride in bulk and Pharmaceutical dosage form.
 https://www.drugbank.ca/drugs/ Valganciclovir hydrochloride.
 https://www.webmd.com/drugs/2/drug-20977/ Valganciclovir-oral/details
 Porter SR, Kaplan JL. Merck index manual of diagnosis and therapy. 19th ed. Merck sharp & Dohme corp: New Jersey; 2011.
 Oâ€™Neil JM, Heckelman EP, Dobbelaar HP, Roman JK, Kenny MC, Karaffa SL. The merck index an encyclopedia of chemicals, drugs and biological, 15thed. Royal society of chemistry: United Kingdom; 2013.
 U.S Pharmacopoeia-National Formulary [USP 34 NF 29]. Vol III. Baltimore. Rockville Md: United States pharmacopoeial convention, united book press; 2011.
 Kar A. Pharmaceutical drug analysis. 2thed. New age international private limited: New Delhi; 2005.
 Sharma BK. Instrumental method of chemical analysis. 23rded. Goel publishing house: Meerut; 2004.
 Willard HH, Merritt LL, Dean JJA, Frank AS. Instrumental method of analysis: 23rded. CBS publishers and Distributers: New Delhi; 1986.
 Schartz ME, Krull IS. Analytical method development and Validation: 1sted. CRC press: US; May 1997.
 Dasari V, Chandu BR, Khagga M, Gindi S. New simple UV spectrophotometric method for the estimation of Valganciclovir in bulk and its formulation. Int J Adv Pharm sci 2010;1(2):282-6.
 Mondal S, Reddy GS, Mondal P, Prathyusha VS, Nair AP, Rahaman ST. Development and Validation of Few UV Spectrophotometric Methods for the Determination of Valganciclovir in Bulk and Pharmaceutical Dosage Form. J Pharm Anal Pharm 2018;9(2):64-8. https://doi.org/10.5530/phm.2018.2.12.
 Awen BZ, Dassari V, Chandu BR, Khagga M, Katakam P. New simple UV Spectrophotometric method for the estimation of Valganciclovir in bulk and its formulation. Int J Pharm Res 2011;2(1):55-8.
 Krishna Veni N, Gowramma B, Madhuri L, Gouthami B, Sindhur Nag N, Meyyanathan SN. Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Valganciclovir Hydrochloride (RS). J Pharm Anal 2014;3(1):19-26.
 Ramesh G, Subba Rao M. Development and Validation of Stability Indicating RP-HPLC Method for Quantitative Determination of Valganciclovir in Pure and Pharmaceutical Formulations. Int J Pharm Res 2015;3(1):1-14.
 Sawant S, Barge V. A Validated Stability Indicating RP-HPLC Method for Valganciclovir, Identification and Characterization of forced Degradation Products of Valganciclovir Using LC-MS/MS. Acta Chromatographica 2014;29(1):29-42. https://doi.org/10.1556/AChrom.26.2014.1.4.
 Mondal S, Reddy GS, Mondal P, Prathyusha VS, Nair AP, Rahaman ST. A New Stability Indicating Ultra Performance Liquid Chromatography-PDA Method for the Estimation of Valganciclovir in Bulk and Tablet Dosage Form. J Pharm Anal Pharm 2018;9(2):94-8. https://doi.org/10.5530/phm.2018.2.16.
 Surekha ML, Swamy GK. High performance thin layer chromatographic method for determination of Valgacyclovir in tablet dosage form. Bull Pharm Med Sci 2013;1(1):44-8.
 Annapurna MM, Tulasi KL, Sirichandra M. Stability indicating Liquid chromatographic method for the quantitative determination of Valganciclovir in pharmaceutical dosage forms J Drug Deliv Ther. 2013;3(3):64-70. https://doi.org/10.22270/jddt.v3i3.498.
 Malleswara Rao SN, Srinivas K, Suryanarayana MV, Madhavan P, Mukkanti K. A Validated LC Method for the Determination of Chiral Purity of (S)-2-azido3-methylbutanoic acid: A key Raw material of Valganciclovir hydrochloride. J Chem Pharm Res 2011;3(4):22-28.
 Sura S, Modalavalasa RR, Chandra Sekhar KB. Development and Validation of Stability Indicating RP-Liquid Chromatographic Method for the Quantitative Determination of Valganciclovir. Der Pharma Chemica 2017;9(19):101-109.
 ICH, Q2 (R1) Validation of Analytical Procedures: text and methodology. European medicine agency: United Kingdom; June 1995.