Development and Validation of RP-HPLC Method for Quantification of Repaglinide in mPEG-PCL Polymeric Nanoparticles: QbD-Driven Optimization, Force Degradation Study, and Assessment of In vitro Release Mathematic Modeling

2021 ◽  
pp. 106491
Author(s):  
Geetika Wadhwa ◽  
Kowthavarapu Venkata Krishna ◽  
Sunil Kumar Dubey ◽  
Rajeev Taliyan
Keyword(s):  
Polymeric Nanoparticles ◽  
In Vitro Release ◽  
Hplc Method ◽  
Degradation Study ◽  
Rp Hplc ◽  
Mathematic Modeling ◽  
Development And Validation ◽  
Vitro Release

scholarly journals Validation of an RP-HPLC Method for the Determination of Asenapine Maleate in Dissolution Media and Application to Study In Vitro Release from Co-Crystals

2021 ◽  
Vol 89 (1) ◽  
pp. 14
Author(s):  
Suhair S. Al-Nimry ◽  
Mai S. Khanfar
Keyword(s):  
In Vitro Release ◽  
Bipolar Disorders ◽  
Aqueous Solubility ◽  
Hplc Method ◽  
In Vitro Dissolution ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Vitro Release

Asenapine maleate is an antipsychotic drug that is indicated in the treatment of schizophrenia and bipolar disorders. It has low aqueous solubility and high permeability (Class II drug) and undergoes an extensive first pass effect. These problems result in low oral bioavailability (<2%). To enhance its solubility/dissolution rate and hence bioavailability, co-crystals using different co-formers in different ratios were prepared and evaluated. To study the in vitro dissolution of the drug from these co-crystals into phosphate buffer (pH 6.8), an RP-HPLC method was developed and validated according to the ICH Q2R1 guidelines. The method was linear in the range 0.1–14 µg/mL (R > 0.9998) and accurate and precise. An ANOVA test indicated that calibration curves run on different days did not differ significantly. It was sensitive (lower limit of quantitation (LLOQ) = 25.03 ng/mL), specific (the co-formers did not interfere with the determination of the drug), and robust to small changes in the mobile phase (pH, composition, and flow rate). The in vitro release of asenapine maleate from the co-crystals and the physical mixture was much enhanced when compared to the in vitro dissolution of the unprocessed drug. In conclusion, the developed and validated RP-HPLC method met the acceptance criteria and was applied successfully in evaluating the in vitro release of the drug.

Development and validation of an in vitro release method for topical particulate delivery systems

2015 ◽  
Vol 485 (1-2) ◽  
pp. 202-214 ◽  
Author(s):  
Maja Lusina Kregar ◽  
Marjana Dürrigl ◽  
Andrea Rožman ◽  
Želimir Jelčić ◽  
Biserka Cetina-Čižmek ◽  
...  
Keyword(s):  
In Vitro Release ◽  
Delivery Systems ◽  
Particulate Delivery ◽  
Development And Validation ◽  
Release Method ◽  
Vitro Release

LINAGLIPTIN AND GLICLAZIDE DI-LOADED EXTENDED-RELEASE NANOPARTICLES: FORMULATION AND EVALUATION

2021 ◽  
Vol 74 (9) ◽  
pp. 2315-2322
Author(s):  
Firas Aziz Rahi ◽  
Muath Sheet Mohammed Ameen ◽  
Mohammed Shamil Fayyadh
Keyword(s):  
Particle Size ◽  
Xanthan Gum ◽  
Extended Release ◽  
Hydroxypropyl Methylcellulose ◽  
In Vitro Release ◽  
Entrapment Efficiency ◽  
Hplc Method ◽  
Electronic Microscopy ◽  
Vitro Release

The aim: This work aimed to formulate gliclazide and linagliptin extended-release nanoparticles. Materials and methods: A HPLC method was developed and validated to determine gliclazide and linagliptin at the same time without interference. The nanoparticles were prepared by emulsion solvent evaporation using two polymers, namely hydroxypropyl methylcellulose (HPMC) 4000 cps and xanthan gum. Results: Nanoparticles prepared were characterized for drug contents, production yield and entrapment efficiency, zeta potential, particle size, morphology by transmission electronic microscopy (TEM) and in-vitro release rate. The formulae GLH1, GLX1 and GHX1 showed release of linagliptin more than 75% after 8 hrs. While the only formula among the three (GHX1) showed release of gliclazide more than 80% after 8 h. So, the formula GHX1 showed acceptable release of more than 80% of both gliclazide and linagliptin after 8 h. Conclusions: The formula GHX1 which containing (0.5:1 xanthan gum: drugs) was the best nanoparticles formula which released more than 80% of both drugs after 8 h and could achieve good extended release over 24 h.

Development and validation of a fast RP-HPLC method to determine the analogue of the thyroid hormone, 3,5,3′-triiodothyroacetic acid (TRIAC), in polymeric nanoparticles

2011 ◽  
Vol 3 (9) ◽  
pp. 1936
Author(s):  
Karen C. dos Santos ◽  
Maria Fátima G. F. da Silva ◽  
João B. Fernandes ◽  
Paulo C. Vieira ◽  
Igor Polikarpov ◽  
...  
Keyword(s):  
Thyroid Hormone ◽  
Polymeric Nanoparticles ◽  
Hplc Method ◽  
Rp Hplc ◽  
Development And Validation

scholarly journals RP-HPLC Method Development and Validation for Simultaneous Estimation of Clarithromycin and Paracetamol

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Sadana Gangishetty ◽  
Surajpal Verma
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Development And Validation

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of clarithromycin (CLA) and paracetamol (PCM). C18 column (Kromasil ODS, 5 µm, 250 × 4.6 mm) and a mobile phase containing phosphate buffer (0.05 M) along with 1-octane sulphonic acid sodium salt monohydrate (0.005 M) adjusted to pH 3.2: acetonitrile (50 : 50 v/v) mixture was used for the separation and quantification. The flow rate was 1.0 mL/min and the eluents were detected by UV detector at 205 nm. The retention times were found to be 2.21 and 3.73 mins, respectively. The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75–175 µg/mL for both drugs. The developed method was applied successfully for assay of clarithromycin and paracetamol in their combined in-house developed dosage forms and in vitro dissolution studies.

scholarly journals Development and Validation of HPTLC Method for Estimation of Carbamazepine in Formulations and Its In Vitro Release Study

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Rashmin B. Patel ◽  
Mrunali R. Patel ◽  
Kashyap K. Bhatt ◽  
Bharat G. Patel
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
In Vitro Release ◽  
Analysis Data ◽  
Limit Of Quantitation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Vitro Release

A new, simple, and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of Carbamazepine. Carbamazepine was chromatographed on silica gel 60 F254 TLC plate using ethyl acetate-toluene-methanol (5.0 + 4.0 + 1.0 v/v/v) as mobile phase. Carbamazepine was quantified by densitometric analysis at 285 nm. The method was found to give compact spots for the drug (Rf=0.47 ± 0.01). The linear regression analysis data for the calibration plots showed good linear relationship with r2=.9995 in the concentration range 100–600 ng/spot. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The minimum detectable amount was found to be 16.7 ng/spot, whereas the limit of quantitation was found to be 50.44 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of Carbamazepine. The method was successfully employed for the estimation of equilibrium solubility, quantification of Carbamazepine as a bulk drug, in commercially available preparation, and in-house developed mucoadhesive microemulsion formulations and solution.

scholarly journals In Vitro Release Study of the Polymeric Drug Nanoparticles: Development and Validation of a Novel Method

Pharmaceutics ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 732
Author(s):  
Jingwen Weng ◽  
Henry H. Y. Tong ◽  
Shing Fung Chow
Keyword(s):  
Polymeric Nanoparticles ◽  
Release Kinetics ◽  
In Vitro Release ◽  
The United States ◽  
Drug Nanoparticles ◽  
Polymeric Drug ◽  
Release Study ◽  
Kinetics Of ◽  
Vitro Release

The in vitro release study is a critical test to assess the safety, efficacy, and quality of nanoparticle-based drug delivery systems, but there is no compendial or regulatory standard. The variety of testing methods makes direct comparison among different systems difficult. We herein proposed a novel sample and separate (SS) method by combining the United States Pharmacopeia (USP) apparatus II (paddle) with well-validated centrifugal ultrafiltration (CU) technique that efficiently separated the free drug from nanoparticles. Polymeric drug nanoparticles were prepared by using a four-stream multi-inlet vortex mixer with d-α-tocopheryl polyethylene glycol 1000 succinate as a stabilizer. Itraconazole, cholecalciferol, and flurbiprofen were selected to produce three different nanoparticles with particle size <100 nm. By comparing with the dialysis membrane (DM) method and the SS methods using syringe filters, this novel SS + CU technique was considered the most appropriate in terms of the accuracy and repeatability to provide the in vitro release kinetics of nanoparticles. Interestingly, the DM method appeared to misestimate the release kinetics of nanoparticles through separate mechanisms. This work offers a superior analytical technique for studying in vitro drug release from polymeric nanoparticles, which could benefit the future development of in vitro-in vivo correlation of polymeric nanoparticles.

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