Vol. 8, Issue 4 (2019)

Author(s):
Chirag J Patel and Dimple N Patel

Abstract:
A simple, precise, accurate and reproducible UPLC method was developed for quantitative determination of erythromycin in cleaning validation swab samples and pharmaceutical formulations. Water Acquity UPLC System equipped with quaternary gradient pump, auto sampler, column oven, and photodiode array detector was used for method development and method validation. UPLC column BEH C18, (50 mm x 2.1 mm, 1.7 µm) thermostated at 50°C was used for separation. Mobile Phase-A comprising of a mixture of Buffer solution (2.84gm of Disodium hydrogen phosphate in 1000mL water, pH adjusted to 8.50 ± 0.05 using diluted Orthophosphoric acid solution and thereafter solution filtered through 0.22 µm PVDF filter) and Methanol in the ratio of 35:65 (% v/v) respectively and Mobile Phase-B comprising of Methanol was used. The flow rate and injection volume was 0.5 mL·min−1 and 7.0 μL respectively. The analysis was carried out under the gradient conditions as time (min)/A (v/v): B(v/v); T₀/100:00, T_1.9/100:00, T_2.2/50:50, T_3.7/50:50, T_4.0/100:00, and T_6.0/100:00. The developed method was validated with respect to specificity, linearity, limit of detection and quantification, accuracy and precision. Results of all validation parameters were within the limits as per ICH guidelines.