Analytics of Dipyridamole Modified Release Capsules

Abstract on dipyridamole formulations

A robust headspace gas chromatographic method was developed for the quantitative determination of two chemicals – acetone and isopropyl alcohol – which occur in dipyridamole modified release capsules.

Due to the weakly basic properties of dipyridamole, tartaric acid pellets (TAP) are used as starter cores for this formulations. The API layered pellets might be taste-masked or not, and offer tremendous advantages to the patients, such as

• low variability of gastric emptying
• low dependency on nutrition state
• low risk of localized high drug concentrations in the GI
• reduced risk of sudden dose dumping
• lower intra- and inter-individual variability
• high control on time and place of drug delivery

When the API layered tartaric acid pellets are brought into a capsule formulations, API dosage can be easily controlled by capsule filling. All these aspects increase the patient’s compliance.

About headspace analysis

The headspace gas chromatographic method is a simple, sensitive, accurate, and robust method for the determination of acetone and isopropyl alcohol. These chemicals might occur as matrix liquids in API dispersions. These dispersions are used for spray-layering the API onto the starter cores or other manufacturing processes. Pharmaeutical formulations based on pellet technologies yield high success and can be developed elsewhere.

In the study by Valavala et al. [1] amethod was developed by using fused silica DB-624 (30 m × 0.32 mm × 1.8 µm) column with the flame ionization detector. The method validation was carried out with regard to the guidelines for validation of analytical procedures Q2 demanded by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). All the validation characteristics were meeting the acceptance criteria. Hence, the developed and validated method can be applied for the intended routine analysis.

Summary of the study

The proposed method was validated and found to be precise, accurate, linear, robust, and rugged, and all the validation parameter results were found satisfactory. The described method is suitable for routine analysis of production samples at laboratories. Tartaric acid pellets are a safe and highly controllable transport media for carrying and supporting the dissolution profile of wealy basic drugs.

References

[1] S. Valavala, N. Seelam, S. Tondepu, V. S. K. Jagarlapudi, and V. Sundarmurthy, Journal of Analytical Methods in Chemistry, 8240932 (2018), DOI:10.1155/2018/8240932