Assessing a Mass-Based Method for the Preparation of Low-Dosed Paediatric Capsules with Baclofen and Spironolactone

Despite the steadily improving medical care situation in pediatrics, some drugs are still not available in a suitable dose or dosage form and thus need to be prepared extemporaneously. Capsules can be easily compounded at the hospital and public pharmacies, offering an alternative to liquid formulations. This study aims at testing a mass-based approach for the extemporaneous preparation of low-dose pediatric capsules and investigating systematically the API loss during this procedure. A total of 54 capsule batches were prepared with baclofen and spironolactone as pediatric-relevant drugs. The hard capsules were prepared using three different bulking agents consisting of either mannitol, lactose-monohydrate and microcrystalline cellulose mixed with 0.5% colloidal silica. Capsules were tested according to Ph. Eur. method “2.9.40 Content Uniformity” as well as for occurring powder loss and mass uniformity. The results reveal that the mass-based approach, in general, allows the preparation of low-dose pediatric capsules of appropriate quality. However, absolute quality is highly dependent on the homogeneity of the powder mixture and the use of defined parameters for capsule preparation.

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RP-HPLC Method Development and Validation for the Estimation of Sacubitril and Valsartan in Pharmaceutical Dosage Form

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.01008 ◽

2021 ◽

pp. 5797-5802

Author(s):

G.M. Kadam ◽

A.L. Puyad ◽

T.M. Kalyankar

Keyword(s):

Dosage Form ◽

Method Development ◽

Limit Of Detection ◽

Hplc Method ◽

Content Uniformity ◽

Phase Detection ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Hplc Method Development

A new, economical, simple, accurate, and precise RP-HPLC method was developed for simultaneous assay and content uniformity determination of Sacubitril and Valsartan in bulk and pharmaceutical dosage form. The separation of Sacubitril and Valsartan was achieved within 6 minutes on Phenomenex Luna C18 250 mm x 4.6mm and 5µm Particle Size, column using Acetonitrile: Methanol: Water (30:55:15% v/v/v) as the mobile phase. Detection was carried out at 250 nm wavelength. The retention time of Sacubitril and Valsartan was found to be 2.361 and 3.304 min, respectively. The validation of the developed method was performed in terms of specificity, accuracy, precision, linearity, the limit of detection, the limit of quantification as mentioned in International Conference on Harmonization (ICH) guidelines. The method showed adequate sensitivity concerning linearity, accuracy, and precision over the range 12-36 μg/ml and 13-39 μg/ml for Sacubitril and Valsartan, respectively. The percentage recoveries obtained for Sacubitril and Valsartan were found to be in the range of 98.00 – 102.00 %. The proposed method is suitable for use in quality-control laboratories for quantitative analysis.

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Determination of content uniformity and distribution characteristics of an investigational drug in its tablets dosage form and granule by ICP-AES

Journal of Pharmaceutical and Biomedical Analysis ◽

10.1016/s0731-7085(03)00364-9 ◽

2003 ◽

Vol 33 (5) ◽

pp. 955-961 ◽

Cited By ~ 5

Author(s):

Lei Wang ◽

Michelle Marley ◽

Hossain Jahansouz ◽

Carl Bahnck

Keyword(s):

Dosage Form ◽

Investigational Drug ◽

Content Uniformity ◽

Distribution Characteristics

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An eco-friendly HPLC-UV method for the determination of risedronate in its bulk and tablet dosage form with application to content uniformity, dissolution and stability testing

Saudi Pharmaceutical Journal ◽

10.1016/j.jsps.2020.08.020 ◽

2020 ◽

Vol 28 (11) ◽

pp. 1301-1308

Author(s):

Moustapha E. Moustapha ◽

Mehnaz Kamal ◽

Rania M. Elgamal

Keyword(s):

Dosage Form ◽

Content Uniformity ◽

Stability Testing ◽

Tablet Dosage

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Stability Indicating TLC Method for Quantification of Brexpiprazole in Bulk and Its Pharmaceutical Dosage Form and Determination of Content Uniformity

Journal of Chromatographic Science ◽

10.1093/chromsci/bmz039 ◽

2019 ◽

Vol 57 (7) ◽

pp. 644-652 ◽

Cited By ~ 2

Author(s):

Anjali M Thakkar ◽

Usmangani K Chhalotiya ◽

Nikunj Parekh ◽

Jaineel V Desai ◽

Dimal A Shah

Keyword(s):

Dosage Form ◽

Chemical Oxidation ◽

Forced Degradation ◽

Content Uniformity ◽

Photo Degradation ◽

Pharmaceutical Dosage Form ◽

Dry Heat ◽

Significant Difference ◽

Alkali Hydrolysis

Abstract A sensitive, selective and precise high performance thin layer chromatographic method has been developed and validated for the quantification of Brexpiprazole in bulk drug and in pharmaceutical dosage form. The method employed HPTLC aluminum plates (pre-coated with silica gel 60 F254) as stationary phase while n-butanol was used as mobile phase. The Rf value of Brexpiprazole was observed to be 0.38. The densitometric analysis was carried out in absorbance mode at 215 nm. The linear regression analysis data for the calibration plots showed a good linear relationship for Brexpiprazole over a concentration range of 200–1,600 ng band−1. The limit of detection and limit of quantification for Brexpiprazole was found to be 66 and 200 ng band−1. To find out the possible degradation pathway, forced degradation studies were performed. The stock solutions of Brexpiprazole (1,000 μg mL−1) were subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photo degradation. The drug was found to be susceptible to acid and alkali hydrolysis, chemical oxidation, photo degradation and dry heat. The degraded product peaks were well resolved from the pure drug peak with significant difference in their Rf values. Stressed samples were analyzed using developed HPTLC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of Brexpiprazole in marketed formulation and determination of content uniformity of tablet formulation. Statistical analysis showed that the method is repeatable, selective, and precise.

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