Development and Validation of Stability Indicating HPTLC Method for Pimavanserin Tartrate

DAMLE, MRINALINI C.; PARDESHI, ROSHANI R.; BIDKAR, SHUBHANGI R.

doi:10.22159/ijpps.2023v15i10.48820

Cited by 2 publications

(1 citation statement)

References 14 publications

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“…The HPLC peaks of AXC, CRC, and VNP weren't interfering with the degradation compounds under every one of the stress settings, according to the information gathered (fig. 6), which ascertains the devised "HPLC conditions" specificity attribute and stabilityindicating quality [33][34][35][36]. Almost all peak purities value for AXC, CRC, and VNP peaks in chromatograms of stressed Voqueznatripak sample were beyond peak threshold.…”

Section: Discussionmentioning

confidence: 99%

Quantification and Quality Control of Triple-Drug Combination Employed for Gastric Ulcer Using Stability-Indicating Selective Rp-HPLC Technique

PAVANI,

ARAVIND,

ANNAM

et al. 2024

Int J App Pharm

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Objective: A seven-day regimen consisting of vonoprazan (VNP), amoxicillin (AXC) and clarithromycin (CRC), administered twice daily, has been permitted and reimbursed by health coverage as initial therapy. No technique has been implemented yet to determine the quantities of VNP, AXC, and CRC combination. This work effectively aimed at estimating these medications (VNP, AXC, and CRC) at the same time by developing an HPLC technique that saves money and time. Methods: The VNP, AXC, and CRC were separated in a “Waters” column (C18 nature; 250 mm sized length; 4.6 mm sized internal diameter; 5 µm sized particle; 25 °C temperature). Phosphoric acid (0.1% in water; pH 4.2) and absolute methanol (50:50, v/v) comprise the mobile phase. The drug product, Voqueznatripak, was subjected to hydrolysis, oxidation, photolysis, and thermal stressors with the intent to cause enforced degradation. The suggested "HPLC conditions" were verified in compliance with ICH guidance. Results: The measurements had a linear range of 10–20 µg/ml for VNP and 250–750 µg/ml for AXC and CRC. The AXC, CRC, and VNP had LOQ’s 5.302 µg/ml, 5.487 µg/ml and 0.523 µg/ml, respectively. Precision measurements were<0.2% RSD and accuracy ranges were 99.40% to 101.46%. The newly devised “HPLC conditions” specificity attribute and stability-indicating quality were also validated by forced degradation tests. Conclusion: The newly devised “HPLC conditions” for analysing AXC, CRC, and VNP in formulation dosage form and stability samples might be adapted by quality control laboratories. The devised “HPLC conditions” is qualified and consistent to reveal and detect any probable change in the drug product assessments throughout stability experiments.

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Section: Discussionmentioning

confidence: 99%

Quantification and Quality Control of Triple-Drug Combination Employed for Gastric Ulcer Using Stability-Indicating Selective Rp-HPLC Technique

PAVANI,

ARAVIND,

ANNAM

et al. 2024

Int J App Pharm

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Drug Excipient Adsorption Technique for the Preparation of Low-Dose Tableting

SHANMUKHAN,

G.,

RADHAKRISHNAN

2024

Int J App Pharm

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Objective: This study aimed to improve drug mixability and drug uniformity in personalized medicine low-dose tablet by developing a stable, easily mixable, drug-adsorbed filler. Methods: The research involved adsorbing drug onto filler by using three solvents and drug-to-excipient ratios of 1:50 and 1:75. The drug adsorbed fillers, were analyzed for drug content uniformity and flow properties, which are crucial for accurate dosing and manufacturing of low dose tablet. Results: Formulations T1, T2 and T3 showed similar flow properties, including bulk and tapped densities, Carr's indices, and Hausner ratios. T1 had better flowability with a lower angle of repose (23.97 degrees) compared to T2 (35.42 degrees), T3 (49 degrees), and T4 (39 degrees) and it also had higher drug uniformity (99.89%, 99.54%, 97.12%, 96.83%). Tablet evaluations of TS1, TS2, TS3 and TS4 met standard criteria for weight variation, friability, and hardness criteria, with TS1 showing a quicker disintegration time (2:58 min), indicating faster dissolution and potentially better bioavailability. Dissolution tests showed both exceeded 85% drug release within 30 min, with TS1 achieving a higher release (99.98), suggesting more efficient drug release. Conclusion: The drug-adsorbed filler premix technique effectively ensures drug content uniformity and improves low-dose drug mixing, contributing to the development of safe, efficient low-dose pharmaceuticals.

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Development and Validation of Stability Indicating HPTLC Method for Pimavanserin Tartrate

Cited by 2 publications

References 14 publications

Quantification and Quality Control of Triple-Drug Combination Employed for Gastric Ulcer Using Stability-Indicating Selective Rp-HPLC Technique

Quantification and Quality Control of Triple-Drug Combination Employed for Gastric Ulcer Using Stability-Indicating Selective Rp-HPLC Technique

Drug Excipient Adsorption Technique for the Preparation of Low-Dose Tableting

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