Medroxyprogesterone USP assay with HPLC – INTERNAL ONLY

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ARTICLES, APPNOTES, FAQ (9289)
- AppNotes Library (1888)
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- Frequently Asked Questions?? (3402)
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December 22, 2022
Tanya

AppNotes Alternate Generic Methods / AppNotes Library / AppNotes Listed by Column / AppNotes Pharmaceuticals / AppNotes Reversed Phase Methods / AppNotes RP C18 / ARTICLES, APPNOTES, FAQ

CONFIDENTIAL – INTERNAL ONLY. Click here for public AppNote.

Alternate L1 column used for a USP assay of Medroxyprogesterone

This Similar USP Medroxyprogesterone is easily performed, and the 10 injections overlay below demonstrates run-to-run consistency and great peak symmetry. The peak efficiency is very good and peak tailing guidelines are easily met with RSD values of less than 1.0%.

This demonstrates a good alternate column for your Medroxyprogesterone USP method.

Peak:
Medroxyprogesterone

Method Conditions:
Column: Cogent MicroBee C18™, 5um, 100Å
Catalog No.: 59305-03
Dimensions: 3.9mm x 300mm
Mobile phase: Acetonitrile and water (40:60)
Flow rate: 2.0mL / minute (we used 0.8 mL/min and met allowable changes per USP.) 2.0 mL/min produced too high backpressure for our efficient tubing/systems with this column dimension + packing.
Injection volume: 10 μL
Detection: UV @ 254nm
Sample Preparation: 1.0 mg/mL of Medroxyprogesterone in acetonitrile.
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%

Note 1: For the full method conditions and details, consult the official United States Pharmacopeia–National Formulary (USP–NF.)
Note 2: Medroxyprogesterone is a type of female hormone (progestin) and is used to prevent endometrial hyperplasia (thickening of the lining of the uterus or womb) in women who are taking conjugated estrogens.

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