Development and Validation of Piribedil in Tablet Dosage Form by HPLC: A QbD and OFAT Approach

Mohan, T.S.S. Jagan; Varma, Datla Peda; Bhavyasri, Khagga; Prasad, KDV; Mukkanti, K.; Jogia, Hitesh

doi:10.14233/ajchem.2017.20431

Cited by 4 publications

(5 citation statements)

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“…The LOD and LOQ were determined experimentally by calculating the concentrations yielding peaks to noise ratios of 3 : 1 (LOD) or 10 : 1 (LOQ) as stated by the USP [28]. The proposed and reference methods [29][30][31] were applied to determine the concentration of each drug either alone or in laboratory-prepared mixtures. By recognition of the high values of the percentage recoveries, and low values of t and F parameters [32], the accuracy of the proposed method could be easily proved (table 5).…”

Section: Methods Validationmentioning

confidence: 99%

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Studying the suitability of hybrid micelle liquid chromatography for estimating the lipophilicity of some partial dopamine agonists used to attain the reward circuit

2021

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Three micellar-based mobile phases were developed and optimized for the simultaneous determination of certain partial dopamine agonists that are used to overcome the withdrawal symptoms of abused drugs, namely aripiprazole, pramipexole and piribedil. The studied drugs were separated using micellar liquid chromatography, hybrid micellar liquid chromatography (HMLC) and microemulsion liquid chromatography (MELC). The three developed mobile phases were studied to estimate their suitability for the measurement of log p -values of the studied drugs. Experimental determination of log P m/w values using the three mobile phases demonstrates that HMLC is the mobile phase of choice since the obtained practical log P m/w values were in accordance with the reported log P values, and calculated log P and log D values. An explanation of the obtained results was presented based on the separation retention mechanism for each chromatographic technique. Furthermore, the effect of the pH and the column temperature in HMLC on the practical log P m/w values was studied. To verify its suitability for experimental measurement of log P m/w , HMLC was subjected to full validation according to the United States Pharmacopeia.

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Section: Methods Validationmentioning

confidence: 99%

“…Accuracy and precision data for the proposed HMLC method. studied drug parameter % found reference methods, % found[29][30][31] application of HMLC for the determination of the drugs in pure form Figures between parentheses are the tabulated t and F values at P = 0.05[32].…”

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Studying the suitability of hybrid micelle liquid chromatography for estimating the lipophilicity of some partial dopamine agonists used to attain the reward circuit

2021

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“…Mohan et al reported an assay estimation method of piribedil in the finished dosage form [16] . Basis a careful review of the reported analytical method, we observed that the method's specificity was not ensured by injecting the major known degradation products to rule out any coelution with the parent compound (piribedil).…”

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Implementation of Quality by Design Methodology in Development and Validation of a New Stability-Indicating, Reverse Phase High-Performance Liquid Chromatography Method for the Rapid Estimation of Piribedil in Piribedil Prolonged Release Tablets

Kumar¹,

Sangeetha²,

Reddy³

et al. 2022

IJPS

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Kumar et al.: Quality by Design based Reverse Phase High-Performance Liquid Chromatography Method for Assay of Piribedil in Tablets Piribedil is a diazinane compound used in the treatment of Parkinson's disease. The objective of the current work was to develop a Quality by design based, stability-indicating high-performance liquid chromatography method, with a short runtime to estimate assay in piribedil prolonged release tablets.The assay is an important critical quality attribute of the drug product, which ensures its efficacy. The critical quality attributes were identified and the quality target method profile was defined. Basis of the initial risk assessment, the separation between piribedil and known/unknown degradation products and the sample preparation procedure's robustness were considered critical factors. Phosphate buffer with 0.01 % triethylamine (pH 2.5; 50 mM) and acetonitrile (80:20, v/v) were used as mobile phase. The peaks were resolved using Hypersil gold C18, (4.6×150) mm, 5 µm column within a runtime of 5 min. The mobile phase was pumped at a flow rate of 1.3 ml/min, whereas the column was maintained at 30°. A 5 µl aliquot of each solution was injected and the peak responses were recorded at 238 nm. The critical chromatographic parameters and sample preparation steps were optimized by using Design of experiments and based on its outcome, method operable design ranges were demarcated. An extensive forced degradation study was executed and all the degradant peaks were well separated from the piribedil peak. Piribedil peak was also found homogenous in all the stressed samples. The developed method was validated and found specific, precise, linear, accurate, rugged and robust.

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“…Three different water-insoluble to water-soluble polymer ratios were optimized using a 3 2 full factorial design approach 18 . Coated LCDH granules were evaluated for powder properties such as bulk density, tapped density, Carr"s index, Hausner"s ratio and in-vitro disintegration time, invitro drug release studies, and in-vivo taste evaluation.…”

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confidence: 99%

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2022

IJPSR

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The goal of this study was to develop taste-masked orally disintegrating tablets of the bitter-tasting levocetirizine dihydrochloride (LCDH) to improve the accessibility and adherence of pediatric, elderly, non-cooperative and paraplegic patients. Methods: In the present study, orally disintegrating Levocetirizine dihydrochloride tablets were formulated by direct compression. Taste masking was achieved using a pH-independent polymeric dispersion of Surelease E-7-19040 in combination with Opadry YS-1-19025-A in different ratios. In-vivo taste evaluation was done to see if the tablets produced utilizing the direct compression approach were successfully disguised. Results: The present study investigated uncoated and coated drug substances and prepared tablets of coated LCDH for flow as well as compression behaviour, Fourier Transform Infrared absorption spectra, Differential scanning calorimetry, powder X-ray diffraction, scanning electron microscopy and in-vitro dissolution and disintegration properties. Conclusion: Using a combination of two polymeric dispersions "Sure lease E-1-19040" and "Opadry" coating for the delivery of LCDH, it was shown that a taste-masking evaluation could be performed to identify effective polymer-carriers for the LCDH. INTRODUCTION:Taste is one of the important quality attributes that govern the palatability of the formulation and, in turn acceptability by the patient. The bitter taste is one of the foremost challenges that formulators encounter while working with bitter-taste drug molecules.

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Development and Validation of Piribedil in Tablet Dosage Form by HPLC: A QbD and OFAT Approach

Cited by 4 publications

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Studying the suitability of hybrid micelle liquid chromatography for estimating the lipophilicity of some partial dopamine agonists used to attain the reward circuit

Studying the suitability of hybrid micelle liquid chromatography for estimating the lipophilicity of some partial dopamine agonists used to attain the reward circuit

Implementation of Quality by Design Methodology in Development and Validation of a New Stability-Indicating, Reverse Phase High-Performance Liquid Chromatography Method for the Rapid Estimation of Piribedil in Piribedil Prolonged Release Tablets

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