Stability-indicating RP-HPLC method development and validation for estimation of Mupirocin calcium in bulk and in pharmaceutical formulation

Abstract

BackgroundA simple, rapid, sensitive and selective stability-indicating (RP-HPLC) method is suggested for the determination of Mupirocin calcium in bulk drug and in pharmaceutical formulation. Mupirocin calcium was eluted from a PrincetoneSPHER-100 C8 (250 × 4.6 mm, 5 µm) column with mobile phase consisting of methanol and water (75:25 v/v) pH adjusted to 4 with acetic acid. The gradient was optimized with a flow rate of 1 mL/min and a wavelength of 221 nm.ResultThe complete analytical method validation was successfully carried out as per ICH guidelines. The retrieval study was carried out at 80% to 120% level of working concentration, and results were in the range of 99 to 101%. The linearity was proven in range of 4–24 µg/mL of working concentration with linear regression curve (R2 = 0.999) with limits of detection (LOD) and quantitation (LOQ) being 0.35 and 1.08 µg/mL, respectively. The retention time for Mupirocin calcium was 5.09 min. The method shows good recoveries and intra-day and inter-day relative standard deviations were less than 2%. Validation parameters as ruggedness and robustness were also determined as per ICH guidelines and were found to be satisfactory. For stability study, the drug was exposed to various stress conditions such as acid, base, oxidation and sunlight as per recommendations of ICH guidelines.ConclusionThe developed HPLC method could be successfully used for the estimation of Mupirocin calcium in bulk and in Pharmaceutical formulation. The high recovery and low relative standard deviation confirm the suitability of proposed method that can be employed for the routine analysis in bulk and Pharmaceutical formulation.