Purification process for anti-parasitic fermentation product
First Claim
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1. A process for purifying ivermectin, comprising:
- (a) obtaining substantially impure ivermectin;
(b) loading the substantially impure ivermectin on a chromatographic column suitable for reversed-phase flash column chromatography;
(c) initiating reversed-phase flash chromatography by applying a first volume of an eluent mixture to the column, the eluent mixture comprising acetonitrile, lower alkyl alcohol and water;
(d) establishing an eluent gradient in the column by adding a series of subsequent volumes of the acetonitrile/lower alkyl alcohol/water eluent mixture to the column, wherein each of the first and the subsequent volumes of the eluent mixture has a ratio of acetonitrile to lower alkyl alcohol to water that varies according to a predetermined profile; and
(e) collecting predetermined fractions eluted from the column, the predetermined fractions comprising substantially purified ivermectin.
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Abstract
A process for purifying the bacterial fermentation product ivermectin, particularly for use as a reference standard compound in a governmental regulatory approval process. The process includes the use of reversed-phase flash column chromatography coupled with gradient elution. An exemplary eluent mixture includes acetonitrile, methanol and water.
22 Citations
15 Claims
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1. A process for purifying ivermectin, comprising:
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(a) obtaining substantially impure ivermectin;
(b) loading the substantially impure ivermectin on a chromatographic column suitable for reversed-phase flash column chromatography;
(c) initiating reversed-phase flash chromatography by applying a first volume of an eluent mixture to the column, the eluent mixture comprising acetonitrile, lower alkyl alcohol and water;
(d) establishing an eluent gradient in the column by adding a series of subsequent volumes of the acetonitrile/lower alkyl alcohol/water eluent mixture to the column, wherein each of the first and the subsequent volumes of the eluent mixture has a ratio of acetonitrile to lower alkyl alcohol to water that varies according to a predetermined profile; and
(e) collecting predetermined fractions eluted from the column, the predetermined fractions comprising substantially purified ivermectin. - View Dependent Claims (2, 3, 4, 5, 15)
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6. A process for purifying ivermectin, comprising:
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(a) obtaining substantially impure ivermectin;
(b) loading the substantially impure ivermectin on a chromatographic column suitable for reversed-phase flash column chromatography;
(c) initiating reversed-phase flash chromatography by applying a first volume of an eluent mixture to the column, the eluent mixture comprising acetonitrile, methanol and water;
(d) establishing an eluent gradient in the column by adding a series of subsequent volumes of the acetonitrile/methanol/water eluent mixture to the column, wherein each of the first and the subsequent volumes of the eluent mixture has a ratio of acetonitrile to methanol to water that varies according to a predetermined profile; and
(e) collecting predetermined fractions eluted from the column, the predetermined fractions comprising substantially purified ivermectin. - View Dependent Claims (7, 8, 9, 10)
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11. A process for purifying ivermectin, comprising:
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(a) obtaining substantially impure ivermectin;
(b) loading the substantially impure ivermectin on a chromatographic column suitable for reversed-phase flash column chromatography;
(c) initiating reversed-phase flash chromatography by applying a first volume of an eluent mixture to the column, the eluent mixture comprising acetonitrile, methanol and water;
(d) establishing an eluent gradient in the column by adding a series of subsequent volumes of the acetonitrile/methanol/water eluent mixture to the column, wherein each of the first and in the subsequent volumes of the eluent mixture has a ratio of acetonitrile to methanol to water that varies according to a profile comprising a range from about 0;
5;
5 to about 5;
4;
1; and
(e) collecting predetermined fractions eluted from the column, the predetermined fractions comprising substantially purified ivermectin. - View Dependent Claims (12, 13, 14)
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Specification