Development and validation of an analytical methods for estimation of anti acne drugs with in combination of hydroquinone in topical formulation

Abstract

quotMethod: 1 A sensitive, rapid, precise and accurate RP-HPLC method has been developed for simultaneous estimation of Hydroquinone and Glycolic Acid from their Cream Formulation. The Chromatographic separation was achieved on a reversed-phase Inertsil C18 (4.6 mm I.D. × 250 mm, 5 µm) column using a mobile phase consisting of Buffer (pH 3) -Acetonitrile in the ratio of 95:05% V/V at a flow rate of 0.5mL/min and UV detection at and#955;max 277 nm. The method showed linearity with regression coefficient of Hydroquinone and Glycolic Acid was 0.9991 and 0.9994 over the range of 2-12 µg/mL, 10-60 µg/mL respectively. The mean recoveries were found to be in the range of 99.00 101.00 % for all the components. The method was validated as per the ICH guidelines for linearity, limit of detection, limit of quantification, specificity, accuracy, less precision and robustness. The method can be successfully applied for routine analysis of quantitative determination of Hydroquinone and Glycolic Acid in pharmaceutical dosage form. newlineMethod: 2and3 A simple, sensitive, rapid, precise and accurate RP-HPLC method has been developed for simultaneous estimation of Hydroquinone, Hydrocortisone and Tretinoin from their Cream Formulation. The Chromatographic separation was achieved on a reversed-phase InertsilC18 (4.6 mm I.D. × 250 mm, 5 µm) column using a mobile phase consisting of Buffer (pH 4) 0.05M Potassium Dihydrogen Ortho Phosphate-Methanol in the ratio of 80:20% V/V at a flow rate of 1mL/min and UV detection at and#955;max 243 nm. The method showed linearity with regression coefficient of Hydroquinone, Hydrocortisone and Tretenoin was 0.9994, 0.9995 and 0.9994 over the range of 40-120 µg/mL, 20-60 µg/mL and 0.25-0.75 µg/mL respectively. The mean recoveries were found to be in the range of 99.00 101.00% for all the components. The method was validated as per the ICH guidelines for linearity, limit of detection, limit of quantification, specificity, accuracy, precision and robustness. The method can be successfully applied for routine analysis of