Analisis Farmasi II: Analisa Bahan Aktif dalam Sediaan Semisolid

Summary

This transcript discusses the analysis of active ingredients in semi-solid pharmaceutical formulations, such as ointments, creams, and gels. It explains various instrumental techniques like UV-Vis spectrophotometry, HPLC, and gas chromatography, highlighting their differences and uses based on sample properties. The analysis includes methods for determining the active ingredient's concentration, such as standard addition, internal standards, and external standards. The script also emphasizes challenges in analyzing semi-solid formulations due to the complexity of the matrix and the low concentration of active ingredients. Lastly, it provides guidelines for preparing samples and performing quantitative analysis, along with methods for validating the results.

Takeaways

• 😀 Semi-solid preparations can be divided into three main types: ointments, creams, and gels.
• 😀 Semi-solid preparations contain both aqueous and oily bases, which affect the composition and analysis methods.
• 😀 The matrix plays an important role in the composition of semi-solid preparations, especially in relation to active ingredients.
• 😀 UV-Vis spectrophotometry is a common tool for analyzing active ingredients in semi-solid preparations.
• 😀 Instruments like HPLC and GC are used based on sample characteristics, with HPLC using a liquid phase and GC using a gas phase.
• 😀 When analyzing semi-solid preparations, the choice of instrument is crucial, especially for separating active ingredients from other substances in the sample.
• 😀 Precision and accuracy are key in the analysis of active ingredients in semi-solid preparations. Precision refers to how close measurements are to each other, while accuracy refers to how close they are to the true value.
• 😀 HPLC and GC are often used to separate components based on volatility and the phase movement of the sample.
• 😀 In quantitative analysis, methods such as internal standard, external standard, or standard addition are used to determine the concentration of active ingredients.
• 😀 The method of preparation for analysis is crucial, especially for semi-solid preparations where samples are prepared separately from standards for external standard methods.
• 😀 Gel preparations are analyzed differently from creams, particularly using UV spectrophotometry to determine active ingredient concentration, such as with retinoic acid.

Q & A

What are the three main types of semi-solid dosage forms mentioned in the script?

The three main types of semi-solid dosage forms mentioned are ointments, creams, and gels.

Why is the analysis of semi-solid dosage forms considered challenging?

The analysis of semi-solid dosage forms is challenging because the active ingredient concentration is typically less than 10%, and the matrices and excipients can vary greatly, making the preparation and analysis more complex.

What is the main difference between HPLC and GC in terms of sample analysis?

The main difference is that in HPLC (High-Performance Liquid Chromatography), the mobile phase is a liquid, while in GC (Gas Chromatography), the mobile phase is a gas. The choice between them depends on the volatility of the sample; if the sample is volatile, GC is used.

What role does the matrix play in the analysis of semi-solid dosage forms?

The matrix, which includes materials like excipients and fillers, plays a critical role in determining the structural and chemical characteristics of the semi-solid dosage form, and it must be accounted for during the analysis to accurately isolate the active ingredient.

What does the term 'precision' refer to in the context of analytical methods for semi-solid dosage forms?

Precision refers to the consistency or repeatability of results. A smaller relative standard deviation (RSD) indicates better precision, meaning the measurements are more reliable and consistent.

What is the significance of 'recovery' in the analysis of semi-solid dosage forms?

Recovery refers to the accuracy with which the active ingredient can be quantified during the analysis. It is important because it determines how well the method can extract and quantify the active ingredient from the sample matrix.

What type of analysis method is suggested for identifying and quantifying active ingredients like retinoic acid in semi-solid dosage forms?

The script suggests using techniques such as HPLC or UV-Vis spectroscopy for identifying and quantifying active ingredients like retinoic acid in semi-solid dosage forms, depending on the formulation and nature of the sample.

What is the difference between 'internal standard' and 'external standard' methods in quantitative analysis?

In the internal standard method, a compound of known concentration is added to the sample to account for variability during the analysis. In the external standard method, the sample is compared to a separate, pre-prepared standard solution to determine concentration.

How is the concentration of an active ingredient determined in a semi-solid dosage form like a cream or gel?

The concentration is determined by preparing a standard solution, measuring the sample absorbance or chromatographic response, and comparing it with the known concentration of the standard. Methods like UV-Vis spectroscopy or HPLC are used for this purpose.

What role does 'linear range' play in the preparation and analysis of semi-solid dosage forms?

The linear range refers to the concentration range over which the instrument provides accurate, proportional responses. It is important for sample dilution and ensuring that the active ingredient's concentration falls within the instrument's detectable limits for reliable results.