Development and Validation of LC-MS/MS Method for the Analysis of P-Toluenesulfonicacid, In Antiviral Drug Acyclovir

Reddy, Noor Shabana, K. Dayananda

doi:10.15680/ijirset.2015.0403005

IJIRSET

2015

DOI: 10.15680/ijirset.2015.0403005

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Development and Validation of LC-MS/MS Method for the Analysis of P-Toluenesulfonicacid, In Antiviral Drug Acyclovir

Noor Shabana, K. Dayananda Reddy¹

Abstract: A sensitive and selective liquid chromatographic-tandem mass spectrometric (LC/MS/MS) method was developed and validated for the trace analysis (>1 ppm level) of p-Toluenesulfonicacid, a genotoxic impurity, in acyclovir drug substances. The chromatographic separation was achieved on Symmetry C-18 (150 X 4.6mm, 3.5µm) column using a mobile phase consisting of 5 mM ammonium acetate and methanol (70:30 v/v) at flow rate of 0.4 mL /min. The API-4000 LC/MS/MS was operated on an electrospray in negative mode. The se… Show more

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Analytical Methodologies for the Estimation of Acyclovir as Key Members of Anti-viral Agent: Two Decades in Review

Gupta,

Pathak

2023

CPA

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Herpes simplex virus (HSV) is a viral infection that primarily targets oral and genital organs in humans. Acyclovir is a widely prescribed anti-viral agent used in the infection caused by herpes simplex virus (HSV). This article emphasizes several analytical techniques, including spectrophotometry, High-performance liquid chromatography, High-performance thin-layer liquid chromatography, Ultra performance liquid chromatography, and Liquid chromatography/Mass detection for the quantification of acyclovir in different matrices like biological fluids and Pharmaceutical formulation. In the proposed work, numerous methods for different techniques were extracted from various databases such as Science Direct, Springer, PubMed, SCOPUS, Web of Science, etc. According to the recommendation from the internal conference on harmonization, this review describes how to determine the presence of utilizing acyclovir in different analytical techniques alone or in combination with another drug.

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Analytical Methodologies for the Estimation of Acyclovir as Key Members of Anti-viral Agent: Two Decades in Review

Gupta,

Pathak

2023

CPA

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New LC-MS Method Development and Validation for Quantitative Estimation of 2-Acetoxy Ethyl Acetoxy Methyl Ether in Acyclovir

Mabbu

Sumathi²,

Devanna

2021

RJPT

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The objective of the proposed method is to develop and validate a specific, precise and accurate LC-MS method for the determination of 2-acetoxy ethyl acetoxy methyl ether (AEM) in Acyclovir. An isocratic separation was done by using YMC-PACK PRO C18, (150 x 4.6 mm, 3µm) column with a mobile phase composition of Buffer (0.1% Ammonia in water) : Methanol(25 :75v/v)at a flow rate of 0.4mL/min, diluent solution of 0.2% of 0.1N NaOH in Methanol were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring (MRM) Acquisition mode and possitive polarity mode. The Retention time of AEM was found to be 5.344 minutes, LOD and LOQ were observed at 0.03 ppm and 0.11 ppm concentration respectively by signal to noise ratio method, linearity was found in the concentration range of 0.18-0.55 ppm with correlation coefficient of 0.996 and accuracy in the range of 97.7- 101% was obtained by performing percentage recovery studies. The % RSD was observed to be less than 10% for six replicates said to be precise. The proposed method was validated for accuracy, precision, sensitivity, and linearity successfully employed for quantitative determination of AEM in acyclovir.

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Development and Validation of LC-MS/MS Method for the Analysis of P-Toluenesulfonicacid, In Antiviral Drug Acyclovir

Cited by 2 publications

References 23 publications

Analytical Methodologies for the Estimation of Acyclovir as Key Members of Anti-viral Agent: Two Decades in Review

Analytical Methodologies for the Estimation of Acyclovir as Key Members of Anti-viral Agent: Two Decades in Review

New LC-MS Method Development and Validation for Quantitative Estimation of 2-Acetoxy Ethyl Acetoxy Methyl Ether in Acyclovir

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