A method for determining related substances in voglibose raw materials and preparations

A technology for voglibose and related substances, which is applied in the field of determination of related substances in voglibose raw materials and preparations, and can solve problems such as complex operations, affecting peak conditions, and affecting substance detection

Active Publication Date: 2022-06-14
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there are still problems in actual detection. First, fluorescence detectors are less common than ultraviolet detectors. In addition, voglibose is detected by fluorescence detection method, which requires the use of fluorescent reagents, which is more complicated to operate, and fluorescent reagents Quality, diluent quality, etc. seriously affect the peak situation, resulting in inverted peaks and miscellaneous peaks, which will affect the detection of related substances

Method used

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  • A method for determining related substances in voglibose raw materials and preparations
  • A method for determining related substances in voglibose raw materials and preparations
  • A method for determining related substances in voglibose raw materials and preparations

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Embodiment 1

[0015] Method for determining impurities of related substances in voglipose capsules in high performance liquid phase: the APIs or preparations containing voglipose and related substances are dissolved in diluents and diluted to a concentration of 10mg / mL; Separation of voglipose and related substances with 1-phenyl-3-methyl-5-pyrazolinone and sodium hydroxide as derivatization reagents, octadecyl bonded porous silica gel as filler, and potassium dihydrogen phosphate buffer-acetonitrile mixed solution as the mobile phase; The dilution is water. The column is A C18 column, the mobile phase is pH 7.2 potassium dihydrogen phosphate buffer - acetonitrile (80:20), the flow rate is 0.7ml / min, the column temperature is 35 °C, the detection wavelength is 248 nm.

Embodiment 2

[0017] Method for determining impurities of related substances in voglipose capsules in high performance liquid phase: the APIs or preparations containing voglipose and related substances are dissolved in diluents and diluted to a concentration of 10mg / mL; Separation of voglipose and related substances with 1-phenyl-3-methyl-5-pyrazolinone and sodium hydroxide as derivatization reagents, octadecyl bonded porous silica gel as filler, and potassium dihydrogen phosphate buffer-acetonitrile mixed solution as the mobile phase; The dilution is water. The column is A C18 column, the mobile phase is pH 7.3 potassium dihydrogen phosphate buffer - acetonitrile (80:20), the flow rate is 0.8 ml / min, the column temperature is 30 °C, the detection wavelength is 250 nm.

Embodiment 3

[0019] Method for determining impurities of related substances in voglipose capsules in high performance liquid phase: the APIs or preparations containing voglipose and related substances are dissolved in diluents and diluted to a concentration of 10mg / mL; Separation of voglipose and related substances with 1-phenyl-3-methyl-5-pyrazolinone and sodium hydroxide as derivatization reagents, octadecyl bonded porous silica gel as filler, and potassium dihydrogen phosphate buffer-acetonitrile mixed solution as the mobile phase; The dilution is water. The column is a C18 column, the mobile phase is pH 7.0 potassium dihydrogen phosphate buffer - acetonitrile (80:20), the flow rate is 0.7ml / min, the column temperature is 35 °C, the detection wavelength is 245 nm.

[0020] Chromatographic separation results are attached Figure 1 As shown, the data is shown in Table 1, from the attached Figure 1 It can be seen that the peak retention time of voglipose chromatography is 7.229min, and the se...

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Abstract

The invention discloses a method for determining related substances in voglibose raw materials and preparations. The present invention utilizes 1-phenyl-3-methyl-5-pyrazolone to carry out pre-column derivatization of voglibose and its related substances, and adopts high-performance liquid chromatography to measure voglibose in raw materials and preparations related substances. The invention can separate the related substances of voglibose, and effectively control the quality of voglibose raw materials and preparations. The determination method of the invention has strong specificity, high accuracy, high precision, good durability, and convenient operation, and can effectively control the quality of raw materials and preparations in actual production.

Description

Technical field [0001] The present invention belongs to the field of drug quality detection technology, particularly relates to a voglipose raw material and formulation of the relevant substance determination method. Background [0002] Vogliglibose phosphate is a new generation of α-glucosidase inhibitors that inhibit the disaccharide hydrolase (α-glucosidase) that breaks down disaccharides into monosaccharides in the intestine, thereby delaying the digestion and absorption of sugars, thereby improving postprandial hyperglycemia. The results of the determination of exhaled hydrogen after administration of sucrose load in healthy adults confirmed that the drug has an inhibitory effect on blood glucose elevation at clinical doses. When normal rats are administered orally, this product inhibits the increase in blood glucose after starch, maltose and sucrose loads, and has no inhibitory effect on the increase in blood sugar after glucose, fructose and lactose loads. The study of the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34B01J20/281B01J20/286
CPCG01N30/02G01N30/06G01N30/34B01J20/281B01J20/286G01N2030/067B01J2220/80
Inventor 薛晓霞杜爽
Owner CISEN PHARMA
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