Analysis of Amemixamine Ⅱ Soft Capsules by High Performance Liquid Chromatography

Abstract

The present invention proposes a method for using high-performance liquid chromatography to analyze Amilamine II soft capsules, which contain acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide. For methorphan, HPLC analysis: using octadecylsilane bonded silica gel column as chromatographic column; using sodium octane sulfonate-phosphate buffer solution with pH 2.0-3.0 as mobile phase A; and using acetonitrile or acetonitrile The mixed solution with methanol was used as mobile phase B. This method can simultaneously and effectively detect the four active ingredients in Amimethamine II Soft Capsules, and is simple to operate, fast in analysis, good in repeatability, and has good specificity. It can more effectively and comprehensively control Amimethamine Min Ⅱ soft capsule product quality.

Description

technical field

[0001] The invention belongs to the technical field of drug analysis, in particular, the invention relates to a method for analyzing aminomethamine II soft capsules by using high performance liquid chromatography. Background technique

[0002] Cold is one of the most common respiratory diseases. There are many kinds of medicines for treating colds. Western medicines are very popular because of their relatively transparent safety and quick results. Most cold medicines are compound preparations. For Western medicine, the composition of cold medicine mainly includes the following types of drugs: antipyretic and analgesic drugs, adrenergic receptor agonists, antihistamines, antitussive and expectorant drugs, antiviral drugs Wait. Nightcoldflucoughallergy (English name: Nightcoldflucoughallergy (acetaminophen, dextromethorphanhydrobromide, doxylaminesuccinate, phenylephrinehydrochloride) capsule) is a cold medicine, each capsule contains acetaminophen 325mg, phe...

Examples

Embodiment 1

[0074] Chromatographic conditions:

[0075] High performance liquid chromatograph: Waterse2996, PDA detector; Chromatographic column: AgilentSB-C18, 4.6 * 150mm, 5 μ m; Adopt sodium octane sulfonate concentration to be 3 mmol / L sodium octane sulfonate-phosphate buffer solution (weighing Take 0.65g sodium octane sulfonate and 3.12g sodium dihydrogen phosphate into 1L water, adjust the pH to 2.5 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution, gradient elution The removal conditions are shown in Table 1; flow rate: 1.2 ml / min; detection wavelength: 275 nm; column temperature: 35°C; injection volume: 20 μL.

[0076] Table 1

[0077] time (min)

Mobile phase A (V%)

Mobile phase B (V%)

0

90

10

1

90

10

16

50

50

17

90

10

21

90

10

[0078] Experimental steps:

[0079](1) Preparation of contrast solution: Accurately wei...

Embodiment 2

[0083] Chromatographic conditions:

[0084] High performance liquid chromatograph: Waterse2996, PDA detector; Chromatographic column: AgilentSB-C18, 4.6 * 150mm, 5 μ m; Adopt sodium octane sulfonate concentration to be the sodium octane sulfonate-phosphate buffer solution ( Weigh 0.65g sodium octane sulfonate, 3.12g sodium dihydrogen phosphate into 1L water, adjust pH to 3.0 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution, gradient The elution conditions are shown in Table 1; flow rate: 1.2 ml / min; detection wavelength: 278 nm; column temperature: 35°C; injection volume: 20 μL.

[0085] Experimental procedure: with embodiment 1.

[0086] Its HPLC spectrum is as Figure 4~6 .

Embodiment 3

[0088] Chromatographic conditions:

[0089] High performance liquid chromatograph: Waterse2996, PDA detector; Chromatographic column: AgilentSB-C18, 4.6 * 150mm, 5 μ m; Adopt sodium octane sulfonate concentration to be the sodium octane sulfonate-phosphate buffer solution ( Weigh 0.43g sodium octane sulfonate, 3.12g sodium dihydrogen phosphate into 1L water, adjust pH to 2.5 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution, gradient Elution conditions are shown in Table 1; flow rate: 1.2ml / min; detection wavelength: 275nm; column temperature: 35°C; injection volume: 20μL;

[0090] Experimental procedure: with embodiment 1.

[0091] Its HPLC spectrum is as Figure 7-9 .

technical field

[0001] The invention belongs to the technical field of drug analysis, in particular, the invention relates to a method for analyzing aminomethamine II soft capsules by using high performance liquid chromatography. Background technique

[0002] Cold is one of the most common respiratory diseases. There are many kinds of medicines for treating colds. Western medicines are very popular because of their relatively transparent safety and quick results. Most cold medicines are compound preparations. For Western medicine, the composition of cold medicine mainly includes the following types of drugs: antipyretic and analgesic drugs, adrenergic receptor agonists, antihistamines, antitussive and expectorant drugs, antiviral drugs Wait. Nightcoldflucoughallergy (English name: Nightcoldflucoughallergy (acetaminophen, dextromethorphanhydrobromide, doxylaminesuccinate, phenylephrinehydrochloride) capsule) is a cold medicine, each capsule contains acetaminophen 325mg, phe...

Examples

Embodiment 1

[0074] Chromatographic conditions:

[0075] High performance liquid chromatograph: Waterse2996, PDA detector; Chromatographic column: AgilentSB-C18, 4.6 * 150mm, 5 μ m; Adopt sodium octane sulfonate concentration to be 3 mmol / L sodium octane sulfonate-phosphate buffer solution (weighing Take 0.65g sodium octane sulfonate and 3.12g sodium dihydrogen phosphate into 1L water, adjust the pH to 2.5 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution, gradient elution The removal conditions are shown in Table 1; flow rate: 1.2 ml / min; detection wavelength: 275 nm; column temperature: 35°C; injection volume: 20 μL.

[0076] Table 1

[0077] time (min)

Mobile phase A (V%)

Mobile phase B (V%)

0

90

10

1

90

10

16

50

50

17

90

10

21

90

10

[0078] Experimental steps:

[0079](1) Preparation of contrast solution: Accurately wei...

Embodiment 2

[0083] Chromatographic conditions:

[0084] High performance liquid chromatograph: Waterse2996, PDA detector; Chromatographic column: AgilentSB-C18, 4.6 * 150mm, 5 μ m; Adopt sodium octane sulfonate concentration to be the sodium octane sulfonate-phosphate buffer solution ( Weigh 0.65g sodium octane sulfonate, 3.12g sodium dihydrogen phosphate into 1L water, adjust pH to 3.0 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution, gradient The elution conditions are shown in Table 1; flow rate: 1.2 ml / min; detection wavelength: 278 nm; column temperature: 35°C; injection volume: 20 μL.

[0085] Experimental procedure: with embodiment 1.

[0086] Its HPLC spectrum is as Figure 4~6 .

Embodiment 3

[0088] Chromatographic conditions:

[0089] High performance liquid chromatograph: Waterse2996, PDA detector; Chromatographic column: AgilentSB-C18, 4.6 * 150mm, 5 μ m; Adopt sodium octane sulfonate concentration to be the sodium octane sulfonate-phosphate buffer solution ( Weigh 0.43g sodium octane sulfonate, 3.12g sodium dihydrogen phosphate into 1L water, adjust pH to 2.5 with phosphoric acid, degas, filter) as mobile phase A, use acetonitrile as mobile phase B, carry out gradient elution, gradient Elution conditions are shown in Table 1; flow rate: 1.2ml / min; detection wavelength: 275nm; column temperature: 35°C; injection volume: 20μL;

[0090] Experimental procedure: with embodiment 1.

[0091] Its HPLC spectrum is as Figure 7-9 .

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