Simultaneous estimation for Dicyclomine HCl and Simethicone in bulk and oral liquid drop formulation: an RP-HPLC method development and validation

Abstract

Abstract Background A new, validated, and selective RP-HPLC technique was established for quantitative estimation of Dicyclomine HCl and Simethicone in the pharmaceutical oral liquid drop formulations. The chromatographic conditions were adjusted using Luna C18 (25 cm × 0.46 cm, 5 μm) column, water-methanol mixture (80:20, v/v) as solvent system and pH adjustment up to 7.4 using orthophosphoric acid. The absorbance was observed at 289 nm λmax injecting 20 μl sample solution and maintain the ambient temperature (30 °C) with 1 ml per min flow rate. Results The retention times of Dicyclomine HCl and Simethicone were determined 2.962 and 4.091 min, respectively. The developed analytical technique was validated for accuracy, precision, linearity, specificity, sensitivity, ruggedness, and robustness as per ICH guidelines. The LOD was found to be 0.72 and 0.57 μg per ml for Dicyclomine HCl and Simethicone, respectively. But, LOQ was 2.19 and 1.73 μg per ml, respectively. Conclusions This validated method showed good precision (RSD% < 1) with acceptable linearity (≥ 0.999). Intra- and inter-day relative RSD of retention times and AUC (area under curve) were found to be less than 2.0%. The method was also significantly useful as economic technique for simultaneous quantitative determination of Dicyclomine HCl and Simethicone in the bulk and pharmaceutical formulation.