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

Abstract

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.

Development of a Topical 48-H Release Formulation as an Anti-scarring Treatment for Deep Partial-Thickness Burns

“…The stock solution was diluted in a volumetric flask with deionized water (DIW) to obtain solutions of 3, 5, 10, 15, 20, 25, and 30 μg/ml of PF. Each standard solution was analyzed in triplicate and each point of the calibration curve is the average of the three analyses (17,18).…”

Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study

“…In the study of Thorat et al (2016) an HPLC method for the determination of pirfenidone from tablet dosage form was established. Analytical separation was carried out using an isocratic technique on a reversed phase C18 column (4.6 mm x 150 mm i.d., 5 μm p.s.…”

“…Recovery was between 99.2 and 101.3%. Precision was found as ≤0.6751 (RSD%) (Thorat et al, 2016). Wang et al (2006) established an HPLC method for determination of pirfenidone as an analytical reagent in rat plasma.…”

“…Also, some analytical methods were reported for the determination of pirfenidone from the different matrix which includes pharmaceutical dosage forms and plasma. These are spectrophotometric (Thorat, Padmane, Tajne, & Ittadwar, 2016), spectrofluorometric (Sambhani & Biju, 2018), capillary electrophoresis (Sotgia et al, 2020), high-performance thin layer chromatography (Thorat et al, 2016), gas chromatography (Ma et al, 2017), and HPLC with an ultraviolet detector (Bodempudi, Babur, & Reddy, 2015;Parmar et al, 2014;Ravisankar, Anusha Rani, Devadasu, & Devala Rao, 2014;Thorat et al, 2016), a photodiode array detector (Bodempudi et al, 2015) and a mass spectrometry detector (Tong et al, 2010;Wen et al, 2014) methods.…”

Development of a Validated Stability Indicating Rp-Hplc Method for the Estimation of Pirfenidone in Bulk Drug and Tablet Dosage form

“…The literature survey reveals that there are few reported methods on stability indicating assay of pirfenidone in bulk and dosage form. These includes stability indicating method by HPTLC [3], RP-HPLC method for monitoring impurities in pirfenidone drug substances [4], the study of pharmacokinetics in rate serum by HPTLC [5], estimation of pirfenidone by UV, HPLC, HPTLC [6]. However, there is no report on the development of a validated stability for the estimation of pirfenidone using RP-HPLC method.…”