Development and Validation of Stability Indicating Rp-Uplc Method for the Quantification of Baloxavir Marboxil in Tablet Formulation

Abstract

Objective: Aim of the present work is to develop a simple, accurate and precise stability-indicating method for the quantification of baloxavir marboxil (BLMX) in tablet dosage form by UPLC.
 Methods: Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8 mm) reverse phase column and the mobile phase composition of buffer 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 was processed through a column at a flow rate of 0.3 ml/min. Column oven temperature was maintained at 30 °C and the detection wavelength was processed at 240 nm.
 Results: Retention time of BLMX was found to be 0.87 min. Repeatability of the method was determined in the form of %RSD and the value was 0.2. The percentage mean recovery of the method was found to be 99.47%. LOD, LOQ values obtained from the regression equation of BLMX were 0.69 and 2.10 mg/ml, respectively. Regression equation and correlation coefficient values of BLMX were y = 16994x+7179.2 and 0.9996. Drug was subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 5.96% and 9.55%.
 Conclusion: Retention time and total run time of the drug was decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of BLMX.

Kinetic degradation study for the first licensed anti‐influenza polymerase inhibitor, baloxavir marboxil, using high‐performance liquid chromatography‐mass spectrometry

“…This research highlighted that BXM was very vulnerable to alkaline, oxidative hydrolysis, and Photodegradation at RT, in contrast to the recently reported method [10], which operates at a higher temperature (60°C). However, when acidic and thermal hydrolysis were being used, the degradation rates are nearly same across the two methods, and the difference in outcomes is attributable to the use of various time periods and temperatures.…”

“…As a result of the good stability of BXM in the solidstate under thermal and photolytic stress conditions for a longer time than predetermined intervals, kinetic studies were not performed in these cases due to the high stability of BXM under these conditions for at least 6 h of time intervals. To conclude, the previously reported method [10] utilized a UHPLC technique to study the stability of BXM, but the proposed method has several advantages over the previously reported method, starting with the discovery of Degs and the good Rs of BXM in the presence of its…”

“…According to Acquavia et al [5], published in November 2020, there was no reported analytical method for determining BXM; however, after an extensive search, two reported analytical methods for determining BXM were discovered. The first paper reported an HPLC–MS method for the determination of BXM as a parent drug in biological matrices [9], while the second paper reported a stability‐indicating UHPLC method for the determination of BXM in tablet formulations [10], yet neither of the two reported methods worked on the separation or identification of the degradation products (Degs) of BXM [9, 10].…”

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…”

Stability‐indicating method development and validation for quantitative estimation of assay and organic impurities of antiviral drug baloxavir marboxil in drug substance and pharmaceutical dosage form using HPLC and LC–MS methods

“…A review of the relevant literature uncovered that neither the official monograph nor the pharmacopeia has any procedures for the assaying or testing of BXM impurities in drug substances or drug products. LC-MS or ultra-performance liquid chromatography methods for BXM were found to be inadequate for the impurity profile of the current source of drug substance (Bhadru et al, 2020;Divya & Pawar, 2022;Raveendranath et al, 2020). This was because these methods did not cover all of the degradation impurities that had been identified in our current drug source and formulated BXM.…”