Abstract
NOVEL STABILITY?INDICATING METHOD FOR DETERMINATION OF RELATED SUBSTANCES OF CYANOCOBALAMIN INJECTION USING RP?HPLC

Sreenivas Pippalla*, Suresh Babu Jillelamud, Arjuna Rao Nekkalapudi

ABSTRACT

The main aim is to develop a simple and sensitive method for determining the cyanocobalamin-related impurities (USP and EP Impurities) in an injection dosage form using the reverse-phase high-performance liquid chromatography (RP-HPLC) method. Chromatographies separation on the Cosmicill Adore pH C18 (octadecylsilane) column of the dimension (150 mm × 3.9 mm, 3 μm) was carried out in the gradient mode with mobile phases; Mobile phase A (0.2 % Trifluroacetic buffer pH-3.0), Mobile phase-B: (95 % Acetonitrile: 5 % Water). The mobile phase was pumped at a flow rate of 1.0 mL min−1 and the analyte was monitored with a UV detector at a wavelength of 360 nm. The method was developed and validated under the stress conditions such as acidic, basic, peroxide, thermal, photolytic, and humidity degradation, respectively. The method was validated with respect to specificity, linearity, precision, accuracy, limit of detection, and limit of quantification provided by the ICH guidelines. The results of linear regression analysis of the calibration plot revealed a good linear relationship between response and concentration with a correlation coefficient value of r2 = 0.9999. The accuracy of known impurities was obtained in the range of 94–105 %. The identification limits and limits of quantification of related compounds of cynocobalamin varied between 0.287 to 0.318 ppm, and 0.950-1.052 ppm respectively. Chromatographic interference was not found during the degradation and excipients were detected from the injection. The proposed method was successfully used to estimate the cyanocobalamin-related impurities in a injection dosage form.

Keywords: cyanocobalamin; related impurities; RP-HPLC; stress conditions; injection dosage form.


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