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.
Highlights
IntroductionClindamycin (methyl-7-chloro-6,7,8-trideoxy-6-{[(4R)-1-methyl-4-propyl-L-prolyl]amino}-1-thio-L-threo-αD-galacto-octopyranoside) is a semi-synthetic derivative of lincomycin
Clindamycin phosphate (CP) is the 2-phosphate ester of clindamycin
Phenoxyethanol (PHE), methylparaben (MP), and propylparaben are the common preservatives in aqueous-based topical formulations and to establish their effectiveness throughout their shelf life, monitoring of these preservatives is mandatory in pharmaceutical products [10, 11]
Summary
Clindamycin (methyl-7-chloro-6,7,8-trideoxy-6-{[(4R)-1-methyl-4-propyl-L-prolyl]amino}-1-thio-L-threo-αD-galacto-octopyranoside) is a semi-synthetic derivative of lincomycin. It is an antibiotic effective against Gram-positive aerobes as well as Gram-negative and Gram-positive anaerobic pathogens. Adapalene (ADA) is a third generation synthetic retinoid used in the treatment of acne. It is a highly lipophilic compound, derived from napthoic acid, and chemically designated as 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-napthoic acid [5]. Combination therapy with a topical retinoid and an antimicrobial agent, which addresses the majority of the causative factors of acne, is considered a first-line treatment option for almost all patients.
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