Development of non-aqueous titrimetric and spectrophotometric methods for the determination of valganciclovir hydrochloride in bulk drug and tablets

Abdulrahman, Sameer A. M.; Algethami, Faisal K.; Qarah, Nagib A. S.; Basavaiah, K.; El-Maaiden, Ezzouhra

doi:10.1016/j.pharma.2021.01.010

Cited by 4 publications

(5 citation statements)

References 19 publications

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“…Non-aqueous titration is the most common titrimetric procedure used in the pharmaceutical assays of many drugs [7,15,27]. Non-aqueous titrations are widely used in Volumes I and II of the British Pharmacopeia for the assay of drug substances.…”

Section: Potentiometric Titration Curvementioning

confidence: 99%

“…If we follow the international refereed journals that are concerned with publishing scientific research in the field of drug analysis, we will find that the majority of published research has used the spectrophotometric technique in analysis, directly or indirectly. To name a few, in the estimation of some anti-infective agents in pharmaceuticals, we will find that most of the published research about it used spectroscopic methods [21][22][23][24][25][26][27][28][29][30]. We also find that browsing through the majority of pharmaceutical analysis books finds that all of them give more space in that books to talk about spectrophotometric techniques and their various applications, especially in the field of drug analysis.…”

Section: Introductionmentioning

confidence: 99%

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Spectrophotometric/Titrimetric Drug Analysis

Qarah¹,

El-Maaiden²

2023

Drug Formulation Design

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The importance of pharmaceuticals comes from their direct connection to human life. Therefore, many analysis techniques such as chromatography, spectroscopic methods, and others have been developed for one goal, which is to ensure that the drug reaches humans with high quality. Spectrophotometric and titrimetric methods have been in general use for the last 40 years and over this period have become the most important analytical instrument in the modern-day laboratory. In many applications, other techniques could be employed in pharmaceutical analysis, but none rival UV–visible spectrometry as well as titrimetry, for their simplicity, versatility, speed, accuracy, and cost-effectiveness. This chapter highlights the spectroscopic methods in the ultraviolet and visible regions, as well as the titration methods that are still widely used in the field of pharmaceutical analysis. The types of titrations, as well as the most important reactions used in spectrophotometric methods, are presented. Examples of the most important applications in the field of pharmaceutical analysis are also presented.

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Section: Potentiometric Titration Curvementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Spectrophotometric/Titrimetric Drug Analysis

Qarah¹,

El-Maaiden²

2023

Drug Formulation Design

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“…The advantages of this method including time and labor requirement less, high precision and reference standard are not required 1 . This method is recently used to determine potassium sparing diuretic drug candidates, valganciclovir hydrochloride, sildenafil citrate, and aceclofenac sodium [8][9][10][11] .…”

Section: Fig 2: Decision Tree For Identification and Qualification Of...mentioning

confidence: 99%

Untitled

2022

IJPSR

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Discovery of the drug molecule which has therapeutic values is the backbone of drug development. Pharmaceuticals have an important role in the prevention and treatment of diseases in humans and animals. However, gradual change in the process of drug synthesis from drug development to bulk production is a common complication in the drug development process. This change may result in the formation of impurities. Moreover, impurities can also be formed during transport and storage. The presence of more than the prescribed limit of impurities in the drugs may influence the purpose of the pharmaceuticals. Therefore, the evaluation of pharmaceutical drugs for the identification and quantification of impurities at various stages is essential. Several chemical and instrumental methods are used to assess the impurities. For this purpose, analytical instrumentations and methods play a crucial role. The current review highlights the development of impurities at various stages of drug development and pharmaceutical manufacturing. Moreover, this review put light on the recent advancement in the analysis of pharmaceuticals.

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“…The literature search revealed that no method is known to date for the identification and quantification in the ultra‐trace range (0.83 ppm) of DMNP in the VAL active pharmaceutical ingredient and formulations by LC–MS/MS. 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).…”

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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Development of non-aqueous titrimetric and spectrophotometric methods for the determination of valganciclovir hydrochloride in bulk drug and tablets

Cited by 4 publications

References 19 publications

Spectrophotometric/Titrimetric Drug Analysis

Spectrophotometric/Titrimetric Drug Analysis

Untitled

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

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