Ramya Kuber B, J. Soundarya
Ramya Kuber B1*, J. Soundarya2
1Department of Pharmacognosy, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s university), Tirupati, 517502, Andhra Pradesh, India.
2Department of Pharmaceutical analysis, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s university), Tirupati, 517502, Andhra Pradesh, India.
Volume - 15,
Issue - 12,
Year - 2022
A simple headspace gas chromatographic (HS-GC) is a novel approach for the simultaneous detection of residual solvents such as ethanol has been devised and validated. Valacyclovir in ethanol, acetone, isopropyl alcohol, toluene, and acetic acid utilizing nitrogen as the carrier gas at a 4 mL/min flow rate with DB-620 column (80mx0.22mm) 1.8m inner diameter by using a flame ionization detector (FID). The headspace gas chromatographic technique provides an acceptable symmetry and resolution for all these residual solvents. The suggested method was shown to be satisfactory for determining the residual solvents of five distinct types. The method's validation findings showed that it is specific, exact, accurate, rugged, linear, and robust, with recoveries ranging from 80-120%. The %RSD (Relative Standard Deviation) for six injections should be NMT-10%. The correlation coefficient R2 = 0.999.
Cite this article:
Ramya Kuber B, J. Soundarya. Method Development and Validation for the estimation of Class-2 Residual Solvents in Valacyclovir by HS-GC. Research Journal of Pharmacy and Technology2022; 15(12):5388-1. doi: 10.52711/0974-360X.2022.00908
Ramya Kuber B, J. Soundarya. Method Development and Validation for the estimation of Class-2 Residual Solvents in Valacyclovir by HS-GC. Research Journal of Pharmacy and Technology2022; 15(12):5388-1. doi: 10.52711/0974-360X.2022.00908 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-12-2
1. Ormrod D, Scott L J, and Perry CM, Drugs, ICH guidelines, Q3C(R6)- Impurities: Guidelines for Residual Solvents, International conference on Harmonisation. 2016; 7-20, 2000; 59 (4), 839. DOI : 10.1016/S0939-6411(96)00037-9.
2. Harold M, Nair M, and James MM: Basic Gas Chromatography. A Wiley-Interscience Publication 1997; 1(1): 2-3. DOI : 10.1016/C2009-0-12062-7.
3. Gerda Marie Friedrichsen, Weiqing Chen, Mikael Begtrup, Chao‐Pin Lee, Philip L. Smith, European Journal of Pharmaceutical Sciences. 2002; 16, 1–13. DOI 10.1016/s0928-0987(02)00047-7.
4. Bengi Uslu, SibelA Ozkan, Electrooxidation of the antiviral drug valacyclovir and its square-wave and differential pulse voltammetric determination in pharmaceuticals and human biological fluids Analytical Chemical Acta. 2006; 555, 341–347. Doi:10.1016/j.aca.2005.09.034.
5. Beutner Karl R., Valacyclovir: a review of its antiviral activity, pharmacokinetic properties, and clinical efficacy. Antiviral Research. 1995; Dec;28(4):281-90. DOI: 10.1016/0166-3542(95)00066-6.
6. Ravi Kanneti, Ramadass Rajesh JR. Aravinda Raj, Parloop A. Bhatt., Chromatographia. 2009; 70, 407‐414.DOI:10.1365/s10337-009-1171-3.
7. Patil GD, Yeole PG, Manisha Puranik, Wadher SJ, International Journal of ChemTech Research, A Validated Specific Reverse Phase Liquid Chromatographic Method for the Determination of Valacyclovir in the Presence of its Degradation Products in Bulk Drug and in Tablet Dosage Form. 2009; 1, 16‐26. DOI : 10.1016/j.BFOPCU.2014.09.002.
8. Sheetal Ramya Lahari.N.A. Method Development and Validation of Valacyclovir In Bulk & Tablet Dosage Form By RP HPLC Method. Journal of Pharmacy and Biological Sciences (IOSR-JPBS). 2013; 56-75. DOI: 10.9790/3008-0515675.
9. Sathis Kumar Dinakaran, Durga Naga Prasanthi Botla, Anusha Pothula, Kamala Kassetti1, Harani Avasarala and Ravishankar Kakaraparthy. Spectrophotometric method development and validation for valacyclovir hydrochloride monohydrate and ritonavir in bulk and tablet dosage form using absorption ratio method. Malaysian Journal of Pharmaceutical Sciences. 2013; Vol. 11, No. 2, 21–29. DOI: 10.52711/0974-360X.2021.00567.
10. Konda R.K, Chandu B.R, Challa B.R, and Chandrasekhar K.B, Development and Validation of a Sensitive LC–MS/MS Method for Determination of Valacyclovir in Human Plasma: Application to a Bioequivalence Study. Acta Chromatographica. 2013; DOI: 10.1556/AChrom.25.2013.4.6.
11. Siva Ramakrishna V, Ravi Kumar D., Malleswara Rao N.V.N, and Ram Babu C. Method Development and Determination of Valacyclovir HCl in Pharmaceutical Dosage Forms by Visible Spectrophotometry. International Journal of PharmTech Research. 2012; Vol.4, No.3,pp 1009-1014.DOI:10.1155/2009/546187.