Objective: To establish a method for determining the intrinsic dissolution rate of erythromycin API with discriminatory power. Methods: Four batches of erythromycin active pharmaceutical ingredient (API) produced by different manufacturing processes were selected for analysis. For each batch, three samples (500 mg each) were compressed into compacts at 15 MPa for 5 min. The intrinsic dissolution rate (IDR) was determined using a rotating disk apparatus at a rotation speed of 50 r · min-1. Cumulative dissolution amounts were measured at 5, 10, 15, 20, 30, 45, and 60 min in 500 mL of phosphate buffer solutions at pH 6.8 and pH 6.0, respectively. The linear portion of the initial dissolution curve was used to calculate the IDR. One-way analysis of variance (ANOVA) was performed to assess the differences among batches. This study aimed to establish a discriminatory IDR testing method for erythromycin API. Results: In pH 6.8 phosphate buffer, the RSDs of the intrinsic dissolution rate measurements were all below 10%, with a P-value of 0.460. One-way ANOVA showed an inter-group P-value of 0.634, indicating no significant difference in intrinsic dissolution rates among the four batches of erythromycin API. In pH 6.0 phosphate buffer, the RSDs were below 10% for all batches except one, which was considered to be affected by stability issues. The P-value was 0.212, and the inter-group P-value was 0.002, indicating a significant difference. The four batches of erythromycin API could be divided into two groups based on their intrinsic dissolution rates, consistant with the grouping based on manufacturing process. Conclusion: The method enables reliable determination of the intrinsic dissolution rate of erythromycin and possesses discriminatory capability.
RUAN Hao
,
SITU Zi-jing
,
GENG Xiao-ting
,
LI Song-xian
,
CHEN Shuang
,
ZHENG Wei-xia
,
HONG Li-ya
,
SU Wei-ke
. Development of a discriminatory intrinsic dissolution rate method for erythromycin API*[J]. Chinese Journal of Pharmaceutical Analysis, 2025
, 45(7)
: 1205
-1213
.
DOI: 10.16155/j.0254-1793.2024-0455
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