Development and Validation of RP-UPLC Method for the Determination of Iloperidone, Its Related Compounds and Degradation Products in Bulk and Dosage Form

Landge, Shashikant B.; Jadhav, Sanjay A.; Vishwambar, Shrihari P.; Solanki, Pavankumar V.; Bembalkar, Saroj R.; Mathad, Vijayavitthal T.

doi:10.4236/ajac.2014.514104

Cited by 5 publications

(3 citation statements)

References 18 publications

(8 reference statements)

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“…Hence, confirming the good precision of the assay method. The sensitivity of the method was measured by calculating the LOD and limit of quantification [21]. LOD and LOQ were calculated using GraphPad InStat ® to be 2.97µg/ml and 9 μg/ml, respectively.…”

Section: Resultsmentioning

confidence: 99%

"Enhancement of solubility of a poorly soluble antiplatelet aggregation drug by cogrinding technique"

Bayoumi¹

2018

Asian J Pharm Clin Res

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Objective: The goal of this study was to formulate ticagrelor tablets with enhanced dissolution rate using cogrinding technique. However, it belongs to the biopharmaceutical classification system Class IV molecule, poorly soluble, and permeable.Methods: Various ratios (0.2:1–1.67:1) of povidone (PVP)/drug were used in the formulations. Ticagrelor was coground with different percentage of PVP K 25 (carrier) in a mortar with a pestle for 30 min, then mixed with the rest excipients. A high-performance liquid chromatography stability indicating assay was developed to test the stability of ticagrelor in the selected formulae.Results: The results showed that the presence of PVP in relatively high ratios compared to the drug is desirable for enhancing the dissolution rate of ticagrelor. The best-optimized formulae found were that F8 and F9 which showed good disintegration and dissolution rate of ticagrelor more than 92% after 30 min while the dissolution rate for ticagrelor standard was only 22% after 30 min. Stability studies were performed on the selected formulae F8 and F9. Conclusion: The optimized formulae were evaluated for thickness, weight variation, hardness, friability, dissolution, and accelerated stability study for a period of 6 months. Cogrinding using PVP K 25 proved to enhance the dissolution of ticagrelor which may be due to the formation of a soluble complex between ticagrelor and PVP. The selected formulae F8 and F9 showed good stability.

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Section: Resultsmentioning

confidence: 99%

"Enhancement of solubility of a poorly soluble antiplatelet aggregation drug by cogrinding technique"

Bayoumi¹

2018

Asian J Pharm Clin Res

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“…It includes estimation of ILOP alone or ILOP and its metabolites in biological matrices and in formulations . A stability assay by high‐performance liquid chromatography (HPLC) was also reported . However, to the best of our knowledge, no attempts have been made for the identification of degradation products and systematic study on the degradation behavior of ILOP according to ICH guidelines.…”

Section: Introductionmentioning

confidence: 99%

Identification of stress degradation products of iloperidone using liquid chromatography coupled with an Orbitrap mass spectrometer

Pandeti

Rout

Narender

et al. 2017

Rapid Comm Mass Spectrometry

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“…RP-HPLC methods for assay have an average run time of 15 min and above and may not be suitable for RS, but not in all cases [3] . If multiple analytes are difficult to separate by isocratic method, a gradient change of organic modifiers such as buffer and organic solvent are applied over a constant time for impurities methods along with Ultra-High Performance Liquid-Chromatography (UHPLC) to achieve shorter run times [4][5][6][7] . Gradient elution mode of RP-HPLC employs aqueous buffer solvent in one channel and organic solvent in another channel at standard flow rate but with varying compositions over time to generate a gradient program for elution.…”

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confidence: 99%

Dual Organic Modifier, Solid Core Technology and Quality by Design Based Tripartite Synergistic Model for Development and Validation of Stability Indicating Method by Reverse Phase-High Performance Liquid Chromatography for Assay and Impurities of Etoricoxib Tablets

Kolla¹,

Vallabhaneni²,

Puttagunta³

et al. 2022

IJPS

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Kolla et al.: Quality by Design Based Stability Indicating High Performance Liquid Chromatography Method for Etoricoxib TabletsTripartite synergistic model of solid core technology, dual organic modifiers and combined mixture design was implemented to achieve combined assay and related substances method by reverse phasehigh performance liquid chromatography with short run time, enhanced sensitivity and improved resolution between multiple impurity peaks. pH of mobile phase, ternary mobile phase composition and high performance liquid chromatography column temperature are experimented as variable parameters.Acetonitrile and isopropyl alcohol mixture was experimented as dual organic modifier. Special focus was given to detailed methodology of dealing with elution order changes by assigning negative sign for resolution. Separation of etoricoxib and related impurities was evaluated as a case study to prove this concept. The method was developed with Ascentis ® Express C 18 , 150×4.6 mm, 2.7 µ column. Mobile phase comprised of buffer (0.1 % v/v ortho phosphoric acid, pH 3.6), acetonitrile and isopropyl alcohol (65.3:29:5.7 v/v) with a flow rate of 1.0 ml/min and ultraviolet detection at 285 nm. Forced degradation studies revealed that the method was stability indicating, suitable for both assay and impurities of drug product. The recoveries for impurities and assay were found to be in the range of 94.0 %-111.0 % and 97.9 %-101.8 %, respectively. Linearity was established for impurities and assay in the range of 0.25-2.0 µg/ml and 125-750 µg/ml, respectively. The method was validated as per international conference on harmonisation guidelines. The method can be successfully employed for determination of assay and impurities of etoricoxib in bulk drugs and formulations.

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Development and Validation of RP-UPLC Method for the Determination of Iloperidone, Its Related Compounds and Degradation Products in Bulk and Dosage Form

Cited by 5 publications

References 18 publications

"Enhancement of solubility of a poorly soluble antiplatelet aggregation drug by cogrinding technique"

"Enhancement of solubility of a poorly soluble antiplatelet aggregation drug by cogrinding technique"

Identification of stress degradation products of iloperidone using liquid chromatography coupled with an Orbitrap mass spectrometer

Dual Organic Modifier, Solid Core Technology and Quality by Design Based Tripartite Synergistic Model for Development and Validation of Stability Indicating Method by Reverse Phase-High Performance Liquid Chromatography for Assay and Impurities of Etoricoxib Tablets

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