Development and validation of a simple and precise analytical technique for the simultaneous quantification of drospirenone and estetrol in bulk and tablets using RP-HPLC

Ms. K. V. Lalitha

Abstract


Aim: For the simultaneous estimate of drospirenone (DSP) and estetrol (ESR), a new oral contraceptive in bulk
and dose forms, a simple methodology was established using RP-HPLC. Methods: Analytes were separated
using Methanol: Phosphate Buffer pH 6.8 adjusted with dil. NaOH (40:60, v/v) as mobile phase pumped at
1.0 ml/min on a Waters C18 Column with 250 mm 4.6 mm i.d. and 5 m particle size. The column temperature was
maintained at 30°C, and a photo diode array detector was used to find an isosbestic point of 215 nm for detection.
With a total run time of 6 min, mobile phase was employed as a diluent. Precision, accuracy, linearity, specificity,
and robustness of the devised methodology were all validated according to ICH recommendations. To establish
the method’s stability indicating nature, forced degradation studies were conducted. Results: ESR and DSP had
retention times of 2.391 and 4.602 min, respectively. Both the drugs exhibited excellent linearity in between
40–120 μg/mL and 189–567 μg/mL for DSP and ESR, respectively. The method was found to be very sensitive.
Conclusion: As a result, the suggested RP-HPLC method for the quantification of DSP and ESR was reliable,
repeatable, accurate, and sensitive.


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DOI: https://doi.org/10.22377/ijgp.v16i2.3256

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