Stability-Indicating LC Method for the Determination of Prasugrel Hydrochloride in Pharmaceutical Dosage Form

Ahirrao, Vinod K.; Patil, C. S.; Bembalkar, Saroj B.; Ubale, Sanjay; Marathe, Rajendra; Nawale, Rajesh B.; Landge, Mahadev G.; Pawar, Rajendra P.

doi:10.3797/scipharm.1201-05

Cited by 13 publications

(7 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The obtained results are reported in Table 1 and the typical representative stressed test samples chromatograms are given in Fig 3. The results of various stress conditions employed to degrade prasugrel hydrochloride drug substance indicated that, prasugrel hydrochloride is susceptible to degrade under acid, alkaline, oxidative, thermal and photolytic conditions, where as it was found be stable in humidity condition. Further, the obtained information from this study is almost comparable with literature [11][12][13] . Further the peak purity data of prasugrel peak at different degradation conditions show that it is homogeneous and there are no coeluting peaks proving that the method is specific and stability indicating for the determination of prasugrel hydrochloride and its related substances.…”

Section: Fig 2: a Typical Representative Hplc Chromatogram Of Prasugsupporting

confidence: 86%

Untitled

2014

IJPSR

View full text Add to dashboard Cite

A gradient reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the determination of Prasugrel hydrochloride and its related substances. The well chromatographic separation of prasugrel from its seven related substances and degradation products was achieved on Sunfire C18, 5m (250mm x 4.6mm) column temperature maintained at 45°C with a mobile phase A: 0.1% v/v orthophosphoric acid in water and mobile phase B: 0.1% v/v orthophosphoric acid in acetonitrile. The flow rate was 1.0mL/min, and the detection wavelength was 220nm. The developed method was validated for specificity, forced degradation studies, sensitivity (LOD and LOQ), linearity, precision (system precision, method precision and intermediate precision), accuracy, stability of standard and sample solutions and robustness. The method is linear with a concentration range of 0.085-3.218µg/ml with correlation coefficients more than 0.9997 for prasugrel and its related substances. The method recoveries obtained are ranged between 96.4% -101.1% for LOQ levels and 94.7%-103.3% for remaining levels. The method was found to be specific, linear, sensitive, precise, rugged, accurate, robust and stability indicating in nature. The more results are detailed in research paper.

show abstract

Section: Fig 2: a Typical Representative Hplc Chromatogram Of Prasugsupporting

confidence: 86%

Untitled

2014

IJPSR

View full text Add to dashboard Cite

show abstract

“…Several studies have used HPLC method for analysis of bulk drug [11], formulation [17], or dietary supplements [9], but are rarely used for biological sample analysis. In addition, the LLOQ values they presented were so high that it was very limited for application in quantifying biological samples.…”

Section: Discussionmentioning

confidence: 99%

“…Although some researchers analyzed epinastine in rat plasma using HPLC-UV, there were common limitations of high LLOQ and long run time [12,13]. Ahirrao et al [11] reported an HPLC-UV analysis of epinastine in bulk drug, and its LLOQ and limit of detection (LOD) were as high as 180 and 50 ng/mL, respectively. The HPLC-UV analysis of epinastine reported by Malakar et al [17] was also for the pharmaceutical dosage form, and the LLOQ was very high as 2 µg/mL.…”

Section: Discussionmentioning

confidence: 99%

“…Finally, the Phenomenex KINETEX core-shell C 18 column (50 × 2.1 mm, 1.7 µm particle size) was selected because it showed relatively good symmetric peak shapes, selectivity, and sensitivity for epinastine quantification. We used a mobile phase with ACN and water containing 0.05% (v/v) trifluoracetic acid [11] or 0.3% (v/v) triethylamine [12] with Phenomenex KINETEX core-shell C 18 column at a flow rate of 0.3 mL/min by gradient elution for epinastine quantification. However, these results were unsatisfactory for chromatograms of epinastine due to low sensitivity and incomplete peak symmetry.…”

Section: Uplc-ms/ms Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetic Comparison of Epinastine Using Developed Human Plasma Assays

et al. 2020

View full text Add to dashboard Cite

The purpose of the study was to develop two new methods, HPLC-UV and UPLC-MS/MS, for quantifying epinastine in human plasma and to compare pharmacokinetic (PK) parameters obtained using them. Even in the same sample, there may be a difference in the quantitative value of drug depending on the assay, so that minor changes in PK parameter values may affect drug dose and usage settings. Therefore, selection and establishment of analytical methods are very important in PK studies of drugs, and a comparison of PK parameters according to analytical methods will be vital. For this study of PK parameter change, we newly developed two methods, HPLC-UV and UPLC-MS/MS, which are most commonly used to quantify epinastine concentrations in human plasma. All developed methods satisfied the international guidelines and criteria for successful application to PK study of 20 mg epinastine hydrochloride tablets after oral administration to twenty-six humans. A comparison of these two methods for in vivo analysis of epinastine was performed for the first time. This comparison study confirmed that different dose and usage settings might be possible based on PK parameters calculated using other analyses. Such changes in calculated PK parameters according to analytical methods would be crucial in the clinic.

show abstract

“…The flow rate was 1.0 mL/min and the detector wavelength was 263 nm. Ahirrao et al [49] developed a simple, rapid, and precise method for the quantitative estimation of prasugrel hydrochloride in pharmaceutical dosage form. A chromatographic separation of prasugrel and its degradants was achieved with Zorbax XDB C8, 150×4.6 mm, 3.5 μm analytical column using aqueous solution of 0.05 M ammonium acetate pH 4.5 with acetic acid-acetonitrile (40:60 v/v).…”

Section: Chromatographymentioning

confidence: 99%

Quantification of Anticoagulants Dabigatran, Rivaroxaban, and Prasugrel by Chromatographic and Spectrometric Techniques – Review

Jayakumari

2019

Asian J Pharm Clin Res

View full text Add to dashboard Cite

A review is presented on different analytical techniques used for quantitative analysis of selected anticoagulants dabigatran, rivaroxaban, and prasugrel. Efforts have been made to collate all the relevant references to the extent possible. The review discusses the advantages and disadvantages of the cited analytical techniques, which will help to give insights into the methods used for estimation of selected anticoagulants such as dabigatran, rivaroxaban, and prasugrel, from clinical isolates, and its dosage forms. The review highlights the basic as well as advanced techniques performed for estimating dabigatran, rivaroxaban, and prasugrel. The techniques illustrated here have been demonstrated to be useful for quantitative determination of selected anticoagulants and may find application in analyzing other related properties.

show abstract

Stability-Indicating LC Method for the Determination of Prasugrel Hydrochloride in Pharmaceutical Dosage Form

Cited by 13 publications

References 11 publications

Untitled

Untitled

Pharmacokinetic Comparison of Epinastine Using Developed Human Plasma Assays

Quantification of Anticoagulants Dabigatran, Rivaroxaban, and Prasugrel by Chromatographic and Spectrometric Techniques – Review

Contact Info

Product

Resources

About