Development and Validation of RP-HPLC Method for the Determination of Enoxaparin in Bulk Drug and Pharmaceutical Dosage Form

Development and Validation of RP-HPLC Method for the Determination of Enoxaparin in Bulk Drug and Pharmaceutical Dosage Form.

SHAH ABDUL BARI*¹, PATEL M SIDDIK², DR.G J KHAN³, MAAZ AAQUIL⁴, SAYAD WAJAHAT⁵.

SHAH ABDUL BARI*¹ DEPARTMENT OF QUALITY ASSURANCE JIIU’S ALI ALLANA COLLEGE OF PHARMACY, AKKALKUWA.DIST: NANDURBAR 425415, MAHARASHTRA, INDIA

ABSTRACT

The reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been       developed to quantify Enoxaparin in raw material and pharmaceutical formulations using C18 analytical reverse-phase column. Enoxaparin API was used as an internal standard. Mobile phase consisted of methanol-water (10:91 v/v), pumped at a flow rate of 0.9 ml/min at ambient temperature and the retention time was about 6.28 min with symmetrical peaks. (enoxaparin) was detected by ultraviolet absorbance at 232 nm with no interference of commonly used excipients. The method was linear over the concentration range 0.5–25 µg/mL (R2 = 0.9995). The limit of detection of enoxaparin was 0.1804 µg/mL and the limit of quantitation was 0.546 µg/ml. The results obtained showed a good agreement with the declared contents in case of pharmaceutical formulations. The proposed method is rapid, accurate, economical and selective and it may be used for the quantitative analysis of metformin in xomparin injection because of its sensitivity and reproducibility.

Keywords: RP-HPLC; metformin; xomparin injection.