Method Development and Validation of Assay of Docusate Sodium in Docusate Sodium Liquid Filled Capsules by HPLC Method
Chinmaykumar Oza
Chinmaykumar Oza, Analytical Chemist, Apnar Pharma LLP 10 Lake Drive, East Windsor, New Jersey, USA.
Manuscript received on 14 January 2025 | First Revised Manuscript received on 21 January 2025 | Second Revised Manuscript received on 04 February 2025 | Manuscript Accepted on 15 February 2025 | Manuscript published on 28 February 2025 | PP: 14-21 | Volume-5 Issue-2, February 2025 | Retrieval Number: 100.1/ijapsr.B406705020225 | DOI: 10.54105/ijapsr.A4067.05020225
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Abstract: Although the USP monograph has provided the method for the determination of % Assay of Docusate sodium in Docusate sodium capsules, it could not produce precise and accurate results in the existing laboratory environment. Thus, the method for the Determination of Assay for Docusate Sodium in Soft Gelatin Capsules was developed on high‐performance liquid Chromatographic (HPLC) using Certified Reference Material Pharmaceutical Secondary Standard. A reversed phase chromatographic method was developed with a reversed‐phase column to quantify the potency of docusate sodium from Soft Gelatin liquid filled Capsule 100mg. The method was validated according to ICH Q2R2 guidelines for Specificity, Precision (System precision, Method precision, Intermediate Precision), Linearity and Accuracy.
Keywords: HPLC, ICH Guidelines, Assay, Docusate Sodium, Soft Gelatin Capsule, Validation.
Scope of the Article: Medicinal Chemistry