title: Validated Stability-Indicating RP-HPLC Method for the Estimation of Degradation Behaviour of Organic Peroxide and Third-Generation Synthetic Retinoids in Topical Pharmaceutical Dosage Formulation.
abstract: The objective of the current study was to establish a validated stability-indicating, high-performance liquid chromatographic method to determine the purity of benzoyl peroxide (BPO) and adapalene (ADP) in the presence of its impurities, forced degradation products, and placebo in pharmaceutical dosage forms. The desired chromatographic separation was achieved on the Kinetex(™) C18 (250 × 4.6 mm, 5 µm) column using gradient elution at 272 nm detection wavelength. The optimized mobile phase consisted of solvent A (mixture of 0.1% v/v glacial acetic acid in water and acetonitrile in the ratio of 80:20 v/v, respectively) and solvent B (mixture of acetonitrile: tetrahydrofuran: methanol in the ratio of 50:30:20 v/v/v, respectively). The stability-indicating capability of the developed method was established by analysing forced degradation samples in which the spectral purity of BPO and ADP along with separation of all degradation products from the analyte peaks was achieved. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness.
authors.affiliation: Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500090, Andhra Pradesh, India; Department of chemistry, National Institute of Technology, Durgapur-713209, West Bengal, India.
authors.forename: Chinmoy
authors.initials: C
authors.lastname: Roy
authors.affiliation: Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500090, Andhra Pradesh, India.
authors.forename: Lalatendu
authors.initials: L
authors.lastname: Panigrahi
authors.affiliation: Department of chemistry, National Institute of Technology, Durgapur-713209, West Bengal, India.
authors.forename: Jitamanyu
authors.initials: J
authors.lastname: Chakrabarty
keywords: Adapalene; Benzoyl peroxide; Degradation; Development; Impurity; Validation
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