Stability Indicating Rp-HPLC Method for Estimation of Repaglinide in Rabbit Plasma

Navamanisubramanian, Raja; Panchagiri, Sabitha; Nerella, Raghunandan; Chamundeeswari, D.; Shanmuganathan, S

doi:10.22159/ijap.2019v11i3.33675

Cited by 4 publications

(2 citation statements)

References 22 publications

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“…The peak area, retention time and %RSD were determined. 20 Forced or stress degradation studies Force degradation studies were performed to determine the stability of NTB in the developed analytical method by exposing it to various stress as discussed below. 21 Acid degradation 0.1 N HCl was added into 4 μg/ml of standard NTB solution, and the solution was subjected to heating by using the reflux condensing method for 60 min at 85°C temperature.…”

Section: Robustnessmentioning

confidence: 99%

A stability indicating method development and validation of a rapid and sensitive RP-HPLC method for Nintedanib and its application in quantification of nanostructured lipid carriers

Velagacherla,

Nayak,

Bhaskar

et al. 2023

F1000Res

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Background: Nintedanib (NTB) is a multiple tyrosine kinase inhibitor, been investigated for many disease conditions like idiopathic pulmonary fibrosis (IPF), systemic sclerosis interstitial lung disease (SSc-ILD) and non-small cell lung cancer (NSCLC). NTB is available as oral capsule formulation, but its ability to detect degradants formed through oxidative, photolytic and hydrolytic processes makes it difficult to quantify. In the current work, a novel reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated. Methods: The developed method is simple, precise, reproducible, stable and accurate. The inherent stability of NTB was evaluated using the proposed analytical method approach and force degradation studies were carried out. NTB was separated chromatographically on the Shimadzu C18 column as stationary phase (250 ×4.6 mm, 5 µm) using an isocratic elution method with 0.1% v/v triethyl amine (TEA) in HPLC grade water and acetonitrile (ACN) in the ratio 35:65% v/v. The mobile phase was pumped at a constant flow rate of 1.0 ml/min, and the eluent was detected at 390 nm wavelength. Results: NTB was eluted at 6.77±0.00 min of retention time (tR) with a correlation coefficient of 0.999, the developed method was linear in the concentration range of 0.5 µg/ml to 4.5 µg/ml. The recovery rate was found to be in the range of 99.391±0.468% for 1.5 µg/ml concentration. Six replicate standards were determined to have an % RSD of 0.04. Conclusion: The formulation excipients didn't interfere with the determination of NTB, demonstrating the specificity of the developed method. The proposed approach of the analytical method developed can be used to quantify the amount of NTB present in bulk drugs and pharmaceutical formulations.

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Section: Robustnessmentioning

confidence: 99%

A stability indicating method development and validation of a rapid and sensitive RP-HPLC method for Nintedanib and its application in quantification of nanostructured lipid carriers

Velagacherla,

Nayak,

Bhaskar

et al. 2023

F1000Res

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“…The particle free clear supernatant (20 µL) was allowed to inject into the HPLC column [C18 (2), 250×4.6 mm; 5µ particle size (Luna®, Phenomenex)] to develop the chromatogram by isocratic elution using a fixed composition of ACN:0.05% trifluoroacetic acid (TFA) in water (55:45, %v/v) mixture as mobile phase, pumped with constant flow rate (1 mL/ min) and 285 nm was set as detection wavelength for entire study. 33…”

Section: In Vivo Study Study Designmentioning

confidence: 99%

Pharmacokinetic Investigation to Study the In Vivo Bioavailability of Thiolated Chitosan Based Repaglinide Buccal Tablets

Navamanisubramanian¹,

Nerella²,

Shanmuganathan

2020

Pharm Sci

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Background: Repaglinide (REP) is an antihyperglycemic drug having low bioavailability due to its extensive first-pass metabolism. The present study aimed to develop and pharmacokinetic investigte the thiolated chitosan (TC) based buccal tablets of REP for improved bioavailability. Methods: TC was prepared by conjugation of L-cysteine with chitosan. The amount of free thiol groups present in TC was determined by UV-spectrophotometry using Ellman’s reagent. TC based REP buccal tablets were prepared by two layers co-compression method and characterized for in vitro and ex vivo parameters. The in vivo performance of prepared REP buccal tablets was assessed by the pharmacokinetic study in New Zealand white rabbits. Results: The prepared TC resulted in 87%w/w yield with 52.3±3.2 μM free thiol functional groups per 10 mg of TC. The prepared formulations have good flow nature and compressibility, acceptable thickness (2.02 to 2.1 mm), weight (60.11 to 61.06 mg), surface pH (6.59 to 6.81) and drug content (98.92 to 101.08 %w/w). The presence of TC significantly improved the mucoadhesion strength, sustained the in vitro release and enhanced the ex vivo permeation of REP buccal tablets. The shelf life of REP buccal tablets was found to be 15.07 months in accelerated storage conditions. The prepared REP buccal tablets (V5) have area under the curve (712.22±15.91 ng/mL/h) and mean residence time (4.66±0.25 h) was 1.89 and 1.83 folds higher than oral bolus respectively. Conclusion: TC based REP buccal tablets are capable of controlled transbuccal release of REP for a prolonged time and have better bioavailability than oral bolus.

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A stability indicating method development and validation of a rapid and sensitive RP-HPLC method for Nintedanib and its application in quantification of nanostructured lipid carriers

Velagacherla,

Nayak,

Bhaskar

et al. 2024

F1000Res

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Background Nintedanib (NTB) is a multiple tyrosine kinase inhibitor, been investigated for many disease conditions like idiopathic pulmonary fibrosis (IPF), systemic sclerosis interstitial lung disease (SSc-ILD) and non-small cell lung cancer (NSCLC). NTB is available as oral capsule formulation, but its ability to detect degradants formed through oxidative, photolytic and hydrolytic processes makes it difficult to quantify. In the current work, a novel reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated. Methods The developed method is simple, precise, reproducible, stable and accurate. The inherent stability of NTB was evaluated using the proposed analytical method approach and force degradation studies were carried out. NTB was separated chromatographically on the Shimadzu C18 column as stationary phase (250 ×4.6 mm, 5 µm) using an isocratic elution method with 0.1% v/v triethyl amine (TEA) in HPLC grade water and acetonitrile (ACN) in the ratio 35:65% v/v. The mobile phase was pumped at a constant flow rate of 1.0 ml/min, and the eluent was detected at 390 nm wavelength. Results NTB was eluted at 6.77±0.00 min of retention time (tR) with a correlation coefficient of 0.999, the developed method was linear in the concentration range of 0.5 µg/ml to 4.5 µg/ml. The recovery rate was found to be in the range of 99.391±0.468% for 1.5 µg/ml concentration. Six replicate standards were determined to have an % RSD of 0.04. Conclusion The formulation excipients didn’t interfere with the determination of NTB, demonstrating the specificity of the developed method. The proposed approach of the analytical method developed can be used to quantify the amount of NTB present in bulk drugs and pharmaceutical formulations.

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Stability Indicating Rp-HPLC Method for Estimation of Repaglinide in Rabbit Plasma

Cited by 4 publications

References 22 publications

A stability indicating method development and validation of a rapid and sensitive RP-HPLC method for Nintedanib and its application in quantification of nanostructured lipid carriers

A stability indicating method development and validation of a rapid and sensitive RP-HPLC method for Nintedanib and its application in quantification of nanostructured lipid carriers

Pharmacokinetic Investigation to Study the In Vivo Bioavailability of Thiolated Chitosan Based Repaglinide Buccal Tablets

A stability indicating method development and validation of a rapid and sensitive RP-HPLC method for Nintedanib and its application in quantification of nanostructured lipid carriers

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