Volume : 13, Issue : 09, September – 2026
Title:
DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF DESOGESTREL AND ETHINYL ESTRADIOL IN BULK AND COMBINED FORM OF PHARMACEUTICAL TABLET DOSAGE FORMS BY USING RP-HPLC ANALYTICAL METHOD
Authors :
G. Vijaya Kumar*, P. Sowjanya, Sambu Harish
Abstract :
A novel, simple, specific, accurate, precise method development and validated for the simultaneous estimation of Desogestrel and Ethinyl Estradiol by RP-HPLC in bulk and marketed formulation. A High Performance Liquid Chromatography WATERS Alliance 2695 separation module, Software: Empower 2, 996 PDA Detector with Phenomenex Luna C18, 100A, 5µm, 250mmx4.6mm i.d. column, with mobile phase composition of Acetonitrile and Buffer pH-3.4 with OPA were taken in the ratio of 55:45% v/v/v was used. The flow rate of 1.0 ml min-1 and effluent was detected at 330 nm. The retention times of Desogestrel and Ethinyl Estradiol was 2.264 and 3.129 minutes. Linearity was observed over concentration range of 6-14µg/ml and 10µg/ml-30µg/ml for Desogestrel and Ethinyl Estradiol respectively. The Limit of detection and limit of quantification of Desogestrel and Ethinyl Estradiol was found to be 0.09ng ml-1 and 0.29ngml-1 & 0.1ng ml-1 and 0.3ngml-1 respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98% to 102%. Then method was validated in terms of linearity, accuracy, precision, (repeatability, intermediate precision) specificity (by assay), robustness and system suitability. Thus, the validated method is can be successfully applied to routine analysis for regulate the quality. It also should be used for analytical research purpose.
Keywords: Desogestrel and Ethinyl Estradiol, RP-HPLC, Method Development, Validation.
Cite This Article:
Please cite this article in press G. Vijaya Kumar et al., Development And Validation For The Simultaneous Determination Of Desogestrel And Ethinyl Estradiol In Bulk And Combined Form Of Pharmaceutical Tablet Dosage Forms By Using Rp-Hplc Analytical Method.,. Indo Am. J. P. Sci, 2026; 13(09).
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