Bioanalytical Method Development and Validation: A Review

Deshpande, Mahesh; Kasture, Veena S.; Mohan, Mahalaxmi; Chavan, Macchindra J

doi:10.5772/intechopen.81620

Cited by 7 publications

(4 citation statements)

References 23 publications

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“…RP-HPLC/UV was chosen for the analysis of glipizide concentrations in the plasma because of its accuracy and selectivity for bioanalytical studies [ 42 , 43 ]. Bioanalysis necessitates plasma sample pretreatment by protein precipitation to eliminate interfering substances and optimize the sensitivity of the analytical procedure [ 44 , 45 ]. On the basis of the optimization results of the protein precipitation method, acetonitrile was selected because it creates the best plasma matrix devoid of interfering chemicals compared with methanol.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic Herb-Drug Interactions of Glipizide with Andrographis paniculata (Burm. f.) and Andrographolide in Normal and Diabetic Rats by Validated HPLC Method

et al. 2022

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Co-administered medicinal herbs can modify a drug’s pharmacokinetics (PK), effectiveness, and toxicity. Andrographis paniculata (Burm. f.) ethanolic extract (APE) and andrographolide (AND) (a potent CYP2C9 inducer/inhibitor) can alter the pharmacokinetic parameters of glipizide (GLZ). This study aimed to determine the potential pharmacokinetics of herb–drug interactions between GLZ and APE/AND in the plasma of normal and diabetic rats using the HPLC bioanalysis method. The glipizide bioanalytical method established with RP-HPLC/UV instrument was validated following the EMA guidelines. GLZ was administered alone and in combination with APE or AND to normal and diabetic rats. The GLZ pharmacokinetic parameters were estimated according to the correlation between concentration and sampling time using the PK solver program. A simple and rapid GLZ bioanalysis technique with a lower limit of quantitation of 25 ng/mL was developed and presented the following parameters: accuracy (error ≤ 15%), precision (CV ≤ 15%), selectivity, stability, and linearity (R2 = 0.998) at concentrations ranging 25–1500 ng/mL. APE administration significantly improved the Cmax and AUC0–t/AUC0–∞ GLZ values in normal and diabetic rats (p < 0.05). AND significantly reduced the bioavailability of GLZ in diabetic rats with small values of T 1/2, Cmax, and AUC0–t/AUC0–∞ (p < 0.05). This combination can be considered in administering medications because it can influence the pharmacological effects of GLZ.

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Section: Discussionmentioning

confidence: 99%

Pharmacokinetic Herb-Drug Interactions of Glipizide with Andrographis paniculata (Burm. f.) and Andrographolide in Normal and Diabetic Rats by Validated HPLC Method

et al. 2022

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“…After centrifugation, the supernatant separated was evaporated at 50±2 ᵒC for 5 min. After appropriate drying, the residue remained was reconstituted with a 200 µl mobile phase mixture [18,19]. It was vortexed for 1 min and further centrifuged at 12,000 rpm for 5 min.…”

Section: Sample Pretreatmentmentioning

confidence: 99%

Development of Quantitative Method of Tulobuterol Hydrochloride in Rat Plasma: Validation and Application to Preclinical Pharmacokinetics

NAZ,

SUBRAHMANYAM,

RACHAMALLA

2023

Int J App Pharm

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Objective: A robust, simple, accurate, rapid, and selective bioanalytical high-performance liquid chromatography (HPLC) method was established and validated to determine the tulobuterol hydrochloride in rat plasma. Methods: The protein precipitation method deproteinated analyte from rat plasma using acetone. The analysis of tulobuterol hydrochloride from rat plasma was accomplished using a mobile phase comprising of methanol: potassium dihydrogen orthophosphate buffer (0.05M; pH 4.0) in 90:10 (v/v) ratio run at 1.0 ml/min flow rate. Separation was carried on BDS hypersil C18 column (4.6 mm × 250 mm; 5 µ) at ambient temperature employing a 996 photodiode array (PDA) detector at 228 nm. Results: The linearity model was exhibited from 100-500 ng/ml with a good correlation of 0.999. Tulobuterol hydrochloride was efficiently separated at a retention time of 7.281 min. The percent recovery rate was between 100.21-100.46 %. The accuracy, precision, robustness, and ruggedness study showed relative standard deviation (%RSD) was within 2% (acceptable limit), and that revealed the method was efficient, precise, reliable, and reproducible. Conclusion: A simple, accurate, suitable method to quantitate tulobuterol hydrochloride in rat plasma was established using HPLC employed with a PDA detector that overcomes the increased cost for analysis. The developed method was successfully validated in rat plasma.

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“…It is generally accepted that peak retention time drift should not exceed a 1.5% coefficient of variation (CV) across multiple injections. 45 The decision of what column length, internal diameter (ID) and pore size to utilize for a given method is largely made based on acceptable run-time and separation or resolution requirements. C18 phases are generally superior at retaining larger, more polar polyphenols while maintaining optimal peak shape; however, retention of smaller and less polar analytes, such as microbial metabolites, can be compromised.…”

Section: Separation (Columns Packing Materials and Mobile Phases)mentioning

confidence: 99%

Berries and Berry Bioactive Compounds in Promoting Health

2022

Food Chemistry, Function and Analysis

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Bioanalytical Method Development and Validation: A Review

Cited by 7 publications

References 23 publications

Pharmacokinetic Herb-Drug Interactions of Glipizide with Andrographis paniculata (Burm. f.) and Andrographolide in Normal and Diabetic Rats by Validated HPLC Method

Pharmacokinetic Herb-Drug Interactions of Glipizide with Andrographis paniculata (Burm. f.) and Andrographolide in Normal and Diabetic Rats by Validated HPLC Method

Development of Quantitative Method of Tulobuterol Hydrochloride in Rat Plasma: Validation and Application to Preclinical Pharmacokinetics

Berries and Berry Bioactive Compounds in Promoting Health

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