Determination of particle size distribution of chiglitazar sodium by laser diffraction method

doi:10.19803/j.1672-8629.20230434

Abstract

Abstract: Objective To establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium so as to provide reference for the development and quality control of methods for determination of drug particle size. Methods The Malvern Mastersizer 3000 laser particle size analyzer with an AEROS dry sampler was used to establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium. As for the AEROS injector, the conditions of determination were as follows: the duration of background measurement was 7 s, the duration of sample measurement was 7 s, obscuration ranged from 0.5% to 5%, the sample dispersion pressure was 0.4 MPa, the injection speed was 60%, high energy venturis were used, and the hopper gap was 2.5 mm. Results The particle size distribution value of the three batches of samples ranged from 1.02 to 1.17 μm in d(0.1), 5.94 to 6.69 μm in d(0.5), and 20.70 to 22.40 μm in d(0.9). The RSD of the above values was below 1%. Conclusion A particle size determination method has been established for chiglitazar sodium, which can provide reference for the development of dry particle size determination methods for other hygroscopic drugs.

Key words: laser diffraction method, chiglitazar sodium, particle size distribution, hygroscopic drugs, dry measurement

CLC Number:

R927.1

GUO Ningzi, LIU Li, YUE Ruiqi, FENG Huiqing, YANG Huaxin, WEI Ningyi, CHEN Hua. Determination of particle size distribution of chiglitazar sodium by laser diffraction method[J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 147-151.

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https://www.zgywjj.com/EN/Y2024/V21/I2/147

References

[1] LIU DX, WU XF, WANG HL, et al.Some considerations on the application of laser diffraction or scattering method in the measurment of the particle size and distribution of API[J]. Chin J New Drug(中国新药杂志), 2022, 31(17): 1689-1692.
[2] SHEN DD, ZENG LG, XU J, et al.Application of the laser particle analyzer to determine the laser particle size of ciclesonide[J].Chin J Antibiot(中国抗生素杂志), 2019, 44(8): 946-952.
[3] HAO F, HU XQ, BA XY, et al.Advances of application of laser diffraction technique of particle size analysis in pharmaceutical quality analysis[J]. Anal Testing Technol Instrum(分析测试技术与仪器), 2017, 23(2): 72-80.
[4] ZHANG YL, FENG Y, LI QX, et al.Establishment and verification of particle size test method of palbociclib by laser light scattering[J]. Chin J Pharm Anal(药物分析杂志), 2019, 39(3): 436-440.
[5] WANG Y, WU S, XUE D, et al.Methodological study of particle size distribution of bromhexine hydrochloride by laser diffraction method[J].Chin J Pharm Anal(药物分析杂志), 2021,41(8): 1448-1453.
[6] WU Y, LIU J, AN Y, et al.Methodological study on particle size distribution of methylcellulose by laser particle analyzer[J]. Chin J Pharm Anal(药物分析杂志), 2019, 39(4): 755-762
[7] The United States Pharmacopeial Convention. U.S.Pharmacopeia 43[S]. The United States Pharmacopeial Convention, 2021.
[8] GUO B, HAO G, QIAN X, et al.Establishment and validation of particle size distribution determination method of Rivaroxaban by laser light scattering[J]. Chin J Pharm Anal(药物分析杂志), 2021, 41(9): 1649-1654.
[9] GENG ZW, HE L, ZHANG MQ, et al.Determination of droplet size of propofol fat emulsion injection[J]. Chin Pharm J(中国药学杂志), 2014, 49(4): 338-343.
[10] GU GZ, WANG YM, LIU W, et al.Determination of efavirenz particle size by laser light scattering method[J]. Chin J Pharm(中国医药工业杂志), 2016, 7(1): 67-70.
[11] GENG ZP, JIANG YY, LI YD, et al.Determination of valsartan particle size by laser light scattering method[J]. Chin J Pharm(中国医药工业杂志), 2017, 48(5): 716-719.
[12] GAO X, CHEN XP, FAN LL, et al.Determination of particle size distribution of fluorometholone eye drops by laser light scattering method[J]. Chin J Pharm Anal(药物分析杂志), 2022, 42(10): 1815-1821.
[13] DI TY, GAO YY, ZHU J, et al.Methodological study of particle size of fluocinonide cream by laser particle analyzer[J]. Chin J Pharm Anal(药物分析杂志), 2016, 36(1): 181-184.
[14] ZHANG HF, YU SS, CAO J, et al.Features and requirements of non-clinical toxic evaluation of inhalable drugs[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(6): 570-578.
[15] GUO NZ, XIN ZS, SUN Y, et al.Determination of size and size distribution of leuprorelin acetate microspheres for injection using laser diffraction method[J]. Chin J New Drugs(中国新药杂志), 2017, 26(8): 886-892.