title: Novel Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Clindamycin Phosphate and Adapalene along with Preservatives in Topical Gel Formulations.
abstract: A novel stability-indicating RP-HPLC method was developed for the simultaneous estimation of clindamycin phosphate (hydrophilic), adapalene (hydro-phobic), phenoxyethanol, and methylparaben in topical gel formulations. Optimum chromatographic separation among the analytes and stress-induced degradants peaks was achieved on the XBridge C18 (50 × 4.6 mm, 3.5 µm) column using a mobile phase consisting of a variable mixture of pH 2.50 ammonium hydrogen phosphate buffer, acetonitrile, and tetrahydrofuran with gradient elution. Detection was performed at 210 nm for phenoxyethanol, methylparaben, and clindamycin phosphate and 321 nm for adapalene. The method was optimized with a unique diluent selection for the extraction of clindamycin phosphate and adapalene from the gel matrix. The developed method was validated for method precision, specificity, LOD and LOQ, linearity, accuracy, robustness, and solution stability as per ICH guidelines. The proposed method can be employed for the quantification of clindamycin phosphate, adapalene, phenoxyethanol, and methylparaben in commercial topical gel formulations.
authors.affiliation: Analytical Research & Development, IPDO, Dr. Reddy's Laboratories, Bachupally, Hyderabad-500072, Andhra Pradesh, India. ; School of Pharmacy, RK University, Kasturbadham, Rajkot-360020, Gujarat, India.
authors.forename: Prakash B
authors.initials: PB
authors.lastname: Modi
authors.affiliation: School of Pharmacy, RK University, Kasturbadham, Rajkot-360020, Gujarat, India. ; Indubhai Patel College of Pharmacy and Research Centre, Dharmaj-388430, Gujarat, India.
authors.forename: Nehal J
authors.initials: NJ
authors.lastname: Shah
keywords: Adapalene; Clindamycin phosphate; Preservatives; Stability indicating