Development and validation of RP-HPLC method for simultaneous estimation of rifampicin, isoniazid and pyrazinamide in human plasma

Prasanthi, B.; Ratna, J. Vijaya; Phani, R. S. Ch.

doi:10.1134/s1061934815080146

Cited by 26 publications

(26 citation statements)

References 15 publications

(9 reference statements)

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“…2. Standard stock solution preparation [9]: The extraction of the plasma samples involved liquid-liquid extraction process. The fixed dosages (10 mg) are spiked in to 10 mL plasma and stored for 24 h. For processing, the stored spiked samples were withdrawn from the freezer and allowed to thaw at room temperature.…”

Section: Methodsmentioning

confidence: 99%

A Bioanalytical Method Development and Validation for Simultaneous Determination of Velpatasvir and Sofosbuvir in Spiked Human Plasma

Phani¹,

Prasad²,

Mallu³

2017

Asian J. Chem.

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INTRODUCTION Sofosbuvir ( Fig. 1) is a prodrug of 2'-deoxy-2'-fluoro-2'-C-methyl-uridine monophosphate that is phosphorylated intra cellularly to the active triphosphate form, used for the treatment of chronic hepatitis C. The nucleoside triphosphate is a nonobligate chain-terminating analogue of UTP that competes for incorporation at the HCV NS5B polymerase active site. Viral RNA synthesis is inhibited secondary to incorporation of the phosphorylated metabolite into nascent viral RNA by the HCV RNA-dependent RNA polymerase [1]. Velpatasvir (Fig. 1) A simple, precise, accurate and sensitive, isocratic RP-HPLC method has been developed and validated for the estimation of velpatasvir and sofosbuvir in plasma. Method was developed with, Intersil ODS C18 column (250 mm × 4.6 mm × 5 µ), mobile phase mixture of acetonitrile and water having pH of 6.5 in the ratio of (80:20 v/v) at flow rate 1 mL/min. at UV detector wavelength of 240 nm. Mobile phase pH was adjusted with 1 % o-phthalaldehyde (OPA). The retention times are 3.49 min for sofosbuvir and 6.15 min for velpatasvir, Quantitative linearity was obeyed in the concentration range of 0.1 to 0.8 µg/mL for sofosbuvir and 0.025 to 0.2 µg/mL for velpatasvir. The limit of detections are 0.006 µg/mL for sofosbuvir, 0.0017 µg/mL for velpatasvir and limit of quantifications are 0.0125 µg/mL for sofosbuvir, 0.003 µg/mL for velpatasvir for which indicates the sensitivity of the method. The average recovery of sofosbuvir is 100.75 and 99.25 % for velpatasvir. The high percentage recovery indicates that the proposed method is highly accurate. Bench top, Auto sampler, Freeze and Thaw stability test are performed.

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Section: Methodsmentioning

confidence: 99%

A Bioanalytical Method Development and Validation for Simultaneous Determination of Velpatasvir and Sofosbuvir in Spiked Human Plasma

Phani¹,

Prasad²,

Mallu³

2017

Asian J. Chem.

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“…Several methods for the detection and quantification of isoniazid from biological fluids and pharmaceuticals have been developed. These approaches use thin layer chromatography (TLC), high performance liquid chromatography) (HPLC), or liquid and gas chromatography coupled to mass spectrometry detectors (GC/MS, LC/MS) [6,7,8,9,10,11,12,13]. However, these techniques require sophisticated and delicate instrumentation and trained laboratory staff and are relatively expensive in terms of maintenance and purchase.…”

Section: Introductionmentioning

confidence: 99%

Optimization and Validation of a Chromatographic Method for the Quantification of Isoniazid in Urine of Tuberculosis Patients According to the European Medicines Agency Guideline

et al. 2018

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Isoniazid is a drug that is widely used against tuberculosis. However, it shows high interpatient variability in metabolism kinetics and clinical effect, which complicates the prescription of the medication and jeopardizes the success of the therapy. Therefore, in a specific patient, the pharmacokinetics of the drug must be elucidated to decide the proper dosage and intake frequency to make the drug suitable for therapeutic drug monitoring. This can be performed by the quantification of the drug in urine as this process is non-invasive and allows the effects of long-time exposure to be inferred. The paper describes the development of a micellar liquid chromatographic method to quantify isoniazid in urine samples. Extraction steps were avoided, making the procedure easy to handle and reducing the waste of toxic organic solvents. Isoniazid was eluted in less than 5 min without interference from other compounds of the urine using a mobile phase containing 0.15 SDS–12.5% 1-propanol (v/v)–Na2HPO4 0.01 M buffered at pH 7, running at 1 mL/min under isocratic mode through a C18 column with the detection wavelength at 265 nm. The method was validated by following the requirements of the Guidelines on Bioanalytical Method Validation issued by the European Medicines Agency (EMA) in terms of selectivity, calibration curve (r2 = 0.9998 in the calibration range (0.03–10.0 μg/mL), limit of detection and quantification (10 and 30 ng/mL respectively), precision (<16.0%), accuracy (−0.9 to +8.5%), carry-over, matrix effect, and robustness. The developed method was applied to quantify isoniazid in urine samples of patients of an Indian hospital with good results. The method was found to be useful for routine analysis to check the amount of isoniazid in these patients and could be used in its therapeutic monitoring.

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“…For the determination of pyz in pharmaceutical preparation and biological sample, various analytical methods has been developed and reported using either UV-Vis spectrophotometry 5,6 , Colorimetry 7,8 or separation technique like chromatographic methods which includes High Performance Thin Layer Chromatography 9 , HighPerformance Liquid Chromatography with different detection mode 10,11 . A few methods have also been reported for the determination of pyz using chromatography after derivatization to increase its selectivity or sensitivity 12 .…”

Section: Introductionmentioning

confidence: 99%

Untitled

2017

IJPSR

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ABSTRACT:Pyrazinamide is an important anti-tubercular drug which shortens the course of TB chemotherapy. A direct injection liquid chromatographic method is developed for the determination of pyrazinamide in pharmaceutical formulation. The method includes a micellar mobile phase containing 0.15M sodium dodecyl sulphate and 1% butanol (v/v) buffered at pH3, a Princeton SPHER-100 C 18 column (250mm × 4.6mm, 5µm particle size) and UV detection was set at 269nm. The Micellar Liquid Chromatography (MLC) method is rapid, precise, sensitive, and robust. In this method pharmaceutical samples were directly injected to the column without pre-treatment step. Under all these conditions, method has very short analysis time of 3.2 min, linearity (r > 0.998), limit of detection and limit of quantification is 1.4, 36.5 ng/ml respectively; Intra -and inter-day precision (RSD%) were 1.5, overall recovery in pharmaceutical formulation is 99.4%, 69.5%, 81.25%, 87.9%. The method is suitable for routine quality control analysis. This chromatographic techniques, MLC has the advantage of avoiding sample extraction step from matrices, thus reduces the time of analysis.

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Development and validation of RP-HPLC method for simultaneous estimation of rifampicin, isoniazid and pyrazinamide in human plasma

Cited by 26 publications

References 15 publications

A Bioanalytical Method Development and Validation for Simultaneous Determination of Velpatasvir and Sofosbuvir in Spiked Human Plasma

A Bioanalytical Method Development and Validation for Simultaneous Determination of Velpatasvir and Sofosbuvir in Spiked Human Plasma

Optimization and Validation of a Chromatographic Method for the Quantification of Isoniazid in Urine of Tuberculosis Patients According to the European Medicines Agency Guideline

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