K. Bhavya Sri1*, G. Sri Vani Shailaja1, Samreen Begum1, Mogili Sumakanth2
1Department of Pharmaceutical Analysis, RBVRR Women's College of Pharmacy, Barkatpura, Hyderabad- 500027, India
2Department of Pharmaceutical Chemistry, RBVRR Women's College of Pharmacy, Barkatpura, Hyderabad- 500027, India
*Address for Corresponding author
Dr. K. Bhavya Sri,
Associate Professor and Head Department of Pharmaceutical Analysis,
RBVRR women's college of Pharmacy, Barkatpura, Hyderabad, India
Abstract
Objective: To develop a simple, sensitive and rapid RP-HPLC method was developed and validated for the quantitative analysis of Enoxaparin sodium in bulk and injectables. Material and methods: A Sunsil C18 column (150mm*4.6mm i.d., 5.0µm) with mobile phase KH2PO4: Methanol in the ratio of 70:30 v/v adjusted 5.2. UV detection was done at 231nm. Results and Conclusion: Linearity was obtained in the concentration range of 5-50 µg/ml. The % recovery of the proposed method for 50%, 100%, 150% was found to be 97.05%-99.14%. The values of %RSD (precision studies) was found to be <2.0%. Limit of detection and quantification was found to be 98µg/ml and 298µg/ml respectively. The developed method was completely validated as per ICH guidelines and satisfactory results were obtained.
Keywords: Enoxaparin sodium, quantitative analysis, RP-HPLC, validation, injectables