Evaluating Ciprofloxacin HCl Stability Under Simulated Microgravity Conditions Using Stability-Indicating HPLC-UV and LC–MS/MS Method

Objective: This study aimed to develop and validate a stability-indicating RP-HPLC-UV method for Ciprofloxacin hydrochloride and to investigate its degradation under simulated microgravity and to identify the degradation products with the use of LC–MS/MS. Methods: The method developed for the stability assessment of ciprofloxacin involved using RP-HPLC, which incorporated a Hibar® C18 (250 mm × 4.6 mm i. d., 5 µm) column, in isocratic mode, with mobile phase comprising of 0.1% formic acid: methanol in the ratio of 70:30 (v/v). The flow rate was 1 ml/min and the detection was monitored at 276 nm. The total run time was 30 min and the column was maintained at ambient temperature. Results: Ciprofloxacin was eluted in the given mobile phase with a retention time (Rt) of 9.3 min. The linearity for the quantification of drug was 10-1000ng/ml (R2 =0.997, y = 1538.5x+802186). The limit of detection and limit of quantification were 0.25 and 0.75 ng/ml, respectively. Recovery of the method was 98 %, while the relative standard deviation (RSD) of intra-day and inter-day precision was 1.5-1.8. The specificity data of the proposed method indicated that with the drug peak no other peak eluted. Furthermore, the well-shaped peaks confirmed the specificity of the method. Conclusion: The proposed RP-HPLC method was simple, sensitive, rapid, cost-effective and accurate for the assessing the stability of ciprofloxacin under stress degradation and simulated microgravity environment.