Mon, 18 Dec 2017

A Newer validated and stability indicating UPLC Method for the Estimation of Nordette in Tablet Formulation

V. Sreeram1*, Prof.M.V.BasaveswaraRao2, A.V.D.Nagendrakumar3, V.N.V.Kishore4

1.Department of chemistry, A.G.&S.G. Siddhartha College of Arts & Science, Vuyyuru, Krishna (Dt) -521165.A.P.INDIA.

2. Department of Chemistry, Dr.M.R.A.R. Campus, Krishna University, Krishna district, A.P.,INDIA.

3. Department of Chemistry, GITAM University, Visakhapatnam-530 045, Andhra Pradesh, India

4. Department of chemistry, A.G.& S.G.Siddhartha College of Arts & Science, Vuyyuru, Krishna (Dt) - 521165.A.P.INDIA


ABSTRACT

A simple, selective, linear, precise and accurate UPLC Method was developed and validated for rapid assay of Nordette in tablet Formulation. Isocratic elution at a flow rate of 0.4ml/min was employed on C8 1.7 µm (2.1 mm x 100 mm) Column at ambient temperature40 °C. Injection Volume was found to be 5.0 µl. The mobile phase consisted of Acetonitrile : Water  60:40 v/v which is filter through a 0.2 µm filter The UV detection wavelength was 220nm and 2µl sample was injected. The retention time for Ethinylestradiol, Levonorgestrel is found to be ± 1.4 minutes and ± 2.1 minutes respectively. A linear regression curve was constructed, and the correlation coefficients (R2) and assessment values calculated. The percentage RSD for both Ethinylestradiol, Levonorgestrel was found to be 1.5%.The Accuracy of method ranges between 97.0 – 102.8%.  The method was validated as per the ICH guidelines. The method was successfully applied for routine quality control analysis of pharmaceutical formulation.

Keywords: Nordette, Ethinylestradiol, Levonorgestrel, UPLC, Recovery, Precise.


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