Simultaneous HPLC Determination of Clindamycin Phosphate, Tretinoin, and Preservatives in Gel Dosage Form Using a Novel Stability-Indicating Method

Abstract

The most well-known, effective medicines for acne therapy are clindamycin phosphate and tretinoin. For the first time, we have developed and validated a reversed-phase HPLC stability-indicating technique for the detection of clindamycin phosphate (CLP), tretinoin (TRN), and two preservatives, methylparaben (MP) and imidazolidinyl urea (IU), simultaneously in this work. Most of the chromatographic conditions in the present study were optimized to achieve better separation. The best separation results were obtained using gradient elution on a C-18 (250 × 4.6 mm), 5 µm column, with a mobile phase consisting of solution A (1 mL/L ortho-phosphoric acid in water) and solution B (methanol), at a flow rate of 1.0 mL/min, with UV detection at wavelengths of 200 nm and 353 nm. Standard parameters such as system suitability, precision, accuracy, specificity, robustness, linearity, range, detection limit, quantification limit, and reagent stability were used to validate the developed technique. According to the standards of the International Council for Harmonization, all of the experimental parameters were found to be within allowable bounds (ICH). The simultaneous concentrations of clindamycin phosphate, tretinoin, methylparaben, and imidazolidinyl urea in pharmaceutical formulations were successfully determined using the suggested approach. The proposed RP-HPLC method detected no interfering peaks in the chromatogram. We may conclude from the data that the new RP-HPLC method can be utilized in pharmaceutical laboratories to simultaneously assess clindamycin phosphate, tretinoin, and two preservatives, methylparaben and imidazolidinyl urea, for both qualitative and quantitative analyses.

Keywords

• RP-HPLC
• clindamycin phosphate
• tretinoin
• imidazolidinyl urea
• methylparaben
• method development and validation