A Validated Stability-Indicating High-Performance Thin-Layer Chromatographic Method for the Estimation of Pirfenidone in Tablet Formulation

Thorat, Sonali G.; Tajne, Madhukar R.; Padmane, S. P; Ittadwar, Abhay

doi:10.1556/1006.2015.28.5.10

Cited by 4 publications

(2 citation statements)

References 5 publications

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“…A single report is available on analytical method for determination of Pirfenidone in tablet/capsule formulation with UV and HPLC method [4], other available methods are from the Stability and pharmacokinetic point of view and needed very tedious process such as liquid-liquid extraction and hence are time consuming and non-economical [5,10]. The earlier reported HPLC method lacks accuracy with respect to peak sharpness and a single method is reported.…”

Section: Resultsmentioning

confidence: 99%

“…Assay or monograph for Pirfenidone or its formulation is not available yet in any pharmacopoeia. Recently we have reported a validated stability-indicating high-performance thin-layer chromatographic method for the estimation of Pirfenidone in tablet formulations [5]. It was learned that recently one report has published HPLC method for determination of Pirfenidone in tablet formulations but this method lacked accuracy and hence we are reporting a better assay including UV and HPTLC along with HPLC method for routine quality control of Pirfenidone formulations [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

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Development and Validation of Simple, Rapid and Sensitive Uv, HPLC and HPTLC Methods for the Estimation of Pirfenidone in Tablet Dosage Form

Thorat

Padmane²,

Tajne

et al. 2016

J. Chil. Chem. Soc.

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UV, HPLC and HPTLC methods were developed and validated for the quantitative determination of Pirfenidone, a novel antifibrotic agent used in idiopathic pulmonary fibrosis. Chromatography was carried out by isocratic technique on reversed phase Eclipse XDB-C 18 column (150 x 4.6 mm, 5µm) with mobile phase consisting of phosphate buff: acetonitrile (pH 3.5) 72:28 v/v at flow rate 1mL/min. TLC was carried out by stationary phase precoated Silica Gel 60 F 254 TLC Plate using mobile phase Toluene: Methanol, 8:2 v/v. The UV spectrophotometric determination was performed at 311nm using solvent methanol. The proposed methods were validated according to ICH Q2-(R1) guidelines. The linearity range for Pirfenidone was 5-70 µg/mL for HPLC, 800-1600 ng/spot for HPTLC and 10-60 µg/mL for UV method. These methods were accurate and precise with recoveries in the range of 98.2-102.32 and relative standard deviation < 2%. The developed methods were successfully applied for determination of Pirfenidone in tablets.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development and Validation of Simple, Rapid and Sensitive Uv, HPLC and HPTLC Methods for the Estimation of Pirfenidone in Tablet Dosage Form

Thorat

Padmane²,

Tajne

et al. 2016

J. Chil. Chem. Soc.

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Fixed-dose dry powder for inhalation of nintedanib, pirfenidone and mycophenolic acid by thin-film freezing (TFF) technology

Praphawatvet

Sahakijpijarn²,

Moon

et al. 2023

Journal of Drug Delivery Science and Technology

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Determination and Pharmacokinetic Study of Pirfenidone in Rat Serum by High-Performance Thin-Layer Chromatography

Thorat

Chikhale

2016

J Chromatogr Sci

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A rapid, sensitive and selective high-performance thin-layer chromatography (HPTLC) method was developed and validated for the determination and pharmacokinetics of pirfenidone in rat serum. One-step protein precipitation by methanol is reported, and serum samples were separated by HPTLC using a simple mobile phase of toluene-methanol in the ratio of 8:2. The retardation factor of pirfenidone in the serum sample was 0.45 with the detection performed at 315 nm. The calibration curve was linear over the range of 100-1,200 ng/spot with a lower limit of quantitation of 40 ng/spot. The mean recovery of pirfenidone in serum was in the range of 70.6-75.8%, and intra-day and inter-day precision were both <14.1%. This method was successfully applied to the pharmacokinetic study of pirfenidone in rats on oral administration of the drug at a dose of 15.0 mg/kg.

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A Validated Stability-Indicating High-Performance Thin-Layer Chromatographic Method for the Estimation of Pirfenidone in Tablet Formulation

Cited by 4 publications

References 5 publications

Development and Validation of Simple, Rapid and Sensitive Uv, HPLC and HPTLC Methods for the Estimation of Pirfenidone in Tablet Dosage Form

Development and Validation of Simple, Rapid and Sensitive Uv, HPLC and HPTLC Methods for the Estimation of Pirfenidone in Tablet Dosage Form

Fixed-dose dry powder for inhalation of nintedanib, pirfenidone and mycophenolic acid by thin-film freezing (TFF) technology

Determination and Pharmacokinetic Study of Pirfenidone in Rat Serum by High-Performance Thin-Layer Chromatography

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