A New Stability Indicating Ultra Performance Liquid Chromatography-PDA Method for the Estimation of Valganciclovir in Bulk and Tablet Dosage Form

Abstract

Background: The present article described about the systemic development of ultra-performance liquid chromatography (UPLC) method for the quantitative determination of valganciclovir in bulk and dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with an HSS (100x2.1 mm, 1.8m).column with an isocratic mobile phase containing a mixture of 0.01N potassium dihydrogen orthophosphate and acetonitrile (55:45 v/v). The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30°C and detection wavelength at 254 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 25 to 150 μg/ml with a correlation coefficient of 0.9997. The recovery of valganciclovir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.933 and 2.827 μg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method. Conclusion: The method is validated according to the ICH guidelines and it is applied successfully for the determination of valganciclovir in tablets.

A Sensitive and Economical Different Spectroscopic Methods Development and Validation for the Quantification of Capecitabine and Stress Degradation Studies

“…It was performed by altering the UVspectrophotometric technique's wavelength (±2 nm). Still, there was no apparent difference in the results within the ICH guidelines [23,24]. The sample evaluation was done six times.…”

Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs

“…The various methods have been used for the quantitative determination of antiviral drugs such as UV, capillary electrophoresis, and Different chromatographic methods likes GC and HPLC, LC-MS, GC-MS. In this review, authors concentrate on stability, suggesting HPLC /RP-HPLC methods for the accurately and effective development and validation of selected antiviral drugs such as, Atazanavir sulfate [35][36], Abacavir [37][38], Acyclovir [39], Adefovir Dipivoxil [41], Boceprevir [42], Baloxavir marboxil [43],Cobicistat [44], Darunavir ethanolate [45][46], Dolutegravir sodium [47][48], Didanosin [49], Efavirenz [50][51][52], Emtricitabine [53], Etravirine [54][55], Famciclovir [56][57][58], Foscarnet [59], Ganciclovir [60], Imiquimod [61], Lamivudine [62], Oseltamivir [63], Ribavirin [64][65], Simeprevir [66][67], Tenofovir [68], Valganciclovir [69][70][71][72], Zanamivir [73] and Zidovudine [74].The selective stability indicating RP-HPLC/ HPLC approaches for different antiviral drugs is summaries in Table .2…”

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

“…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).…”