Development of a RP-LC method for a diastereomeric drug valganciclovir hydrochloride by enhanced approach

Kumar, Ramesh; Hariram, B.; Divya, G.; Srinivasu, M.K.; Srinivas, K.; Sagyam, Rajeshwar Reddy

doi:10.1016/j.jpba.2012.06.010

Cited by 12 publications

(4 citation statements)

References 18 publications

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“…This can be carried out by adjusting one variable at a time or through the use of experimental design strategies, where several variables are jointly optimized within a restricted experimental domain, employing statistical and graphic methodologies. Experimental designs are able to furnish proper conditions with a minimal number of experiments, while also providing the practitioner with better understanding of the effects of modifying different variables on the performance of the chromatographic separation [115,116]. As optimization of many variables may be impractical, the optimization problem can be simplified by establishing conditions for the less critical factors (e.g., injection volume, column temperature, flow-rate, components of the mobile phase, and detection conditions), before submitting the most crucial variables (e.g., column type, composition of the mobile phase, including pH, ionic strength, additives, and modifiers) to closer examination.…”

Section: Methods Optimizationmentioning

confidence: 99%

Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations

Maggio

Vignaduzzo

Kaufman

2013

TrAC Trends in Analytical Chemistry

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Section: Methods Optimizationmentioning

confidence: 99%

Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations

Maggio

Vignaduzzo

Kaufman

2013

TrAC Trends in Analytical Chemistry

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“…Nevertheless, there are several published UV methods for the determination of VAL in both active pharmaceutical ingredients and finished dosage forms (Abdulrahman et al, 2021; Karthik & Sowyma, 2020; Kumar et al, 2014; Mondal, Reddy, et al, 2018). In addition, there are a few reversed‐phase HPLC methods that are also used for the determination of VAL in both active pharmaceutical ingredients and finished dosage forms (Dogan‐Topal et al, 2007; Ganorkar & Shirkhedkar, 2017; Mondal, Sunil Reddy, et al, 2018; Reddy et al, 2014; Suresh Kumar et al, 2012). In addition, there is a capillary electrophoretic and liquid chromatographic method for the determination of VAL in pharmaceutical formulations (Dogan‐Topal et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

A novel liquid chromatography with quadrupole time‐of‐flight‐tandem mass spectroscopy method for ultra‐trace level identification and quantification of the genotoxic impurity 2,6‐diamino‐5‐nitropyrimidin‐4(3H)‐one in valganciclovir hydrochloride

Ali,

Moorthy,

Devanna

2023

Biomedical Chromatography

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In the present study, the main objective is to develop an analytical method for ultra‐trace level measurement of 2,6‐diamino‐5‐nitropyrimidin‐4(3H)‐one (DMNP) in valganciclovir hydrochloride (VAL) using liquid chromatography‐quadrupole time‐of‐flight‐tandem mass spectroscopy (LC–QTOF–MS/MS). In the early stages of guanine synthesis, DMNP is formed, and guanine is known to be the key starting material for the synthesis of VAL. Taking into consideration DMNP potential genotoxicity, this analytical method has been developed. This method is time saving and suitable for confirming the masses of parent and fragment ions by MS and MS/MS further fragmentation. An isocratic program and Acquity UPLC HSS cyano column (100 × 2.1 mm × 1.8 μm) were used to achieve optimal separation between VAL and the DMNP impurity. A 0.1% ammonia solution in Milli‐Q water was used as mobile phase A, and methanol was used as mobile phase B in the ratio 90:10 v/v in isocratic mode. In accordance with the International Conference on Harmonization's requirements, the developed method was validated. The detection and quantification levels were found to be 0.028 and 0.083 ppm respectively. The DMNP impurity is linear from 0.083 to 1.245 ppm levels with correlation coefficient (R2) of 0.9960. The recoveries were found to be 97.0–107.9%.

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“…After then, it was converted to its triphosphate form by cellular kinases. 2 According to a review of the valganciclovir literature, UV methods, [1][2][3] LC-MS methods [4][5][6][7][8] and RP-HPLC methods [9][10][11][12][13] were published up to this point. The study's major objective was to create an easy, precise RP-HPLC method for the measurement of valganciclovir in both pure and tablet dose forms.…”

Section: Introductionmentioning

confidence: 99%

Analytical Method Development and Validation for Determination of Valganciclovir by Using RP-HPLC

Abhigna,

Sundararajan

2023

Int J. Pharm. Investigation

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Objectives: A novel, precise, and accurate RP-HPLC method was developed and validated for the determination of valganciclovir in pure and medicinal dose form. Cytomegalovirus infections were treated with the antiviral medication valganciclovir. Ganciclovir was first phosphorylated by viral protein kinase into the monophosphate form in cytomegalovirus-infected cells. Afterwards, it was converted to its triphosphate form by cellular kinases. Materials and Methods: The analyte separation was obtained by Shimadzu C 18 column. Mobile phase was in the ratio (20:80v/v) of acetonitrile and 0.05% of orthophosphoric acid. Flow rate of 0.6mL/min was used. The wavelength of the drug was at 254nm with a retention time of 3. 761 min. Results: The regression equation of valganciclovir was found to be y=56286x+50633, with a R 2 value of 0. 9993. It was reported that the precision percent RSD was under 2%. The rate of valganciclovir recovery was 99.43%. Valganciclovir LOD and LOQ were determined to be 0.1 µg/mL and 0.3µg/mL, respectively. Conclusion:The proposed method was shown to be exact, accurate, and perfect for usage in QC labs for quantitative analysis of pharmaceutical dosage forms, both single and combined.

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Development of a RP-LC method for a diastereomeric drug valganciclovir hydrochloride by enhanced approach

Cited by 12 publications

References 18 publications

Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations

Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations

A novel liquid chromatography with quadrupole time‐of‐flight‐tandem mass spectroscopy method for ultra‐trace level identification and quantification of the genotoxic impurity 2,6‐diamino‐5‐nitropyrimidin‐4(3H)‐one in valganciclovir hydrochloride

Analytical Method Development and Validation for Determination of Valganciclovir by Using RP-HPLC

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