Evaluation of an Automated Dual-Channel Hydroxylamine Assay Procedure for Formulated Penicillin Products. I. Liquid Formulations

Abstract The automated dual-channel hydroxylamine method reported by Stevenson, Bechtel, and Coursen was compared with the official Food and Drug Administration (FDA) manual iodometric method used to determine the potency of formulated penicillin products. In order to assay a wide range of products, the liquid sampler module was used with 4 different flow diagram arrangements for liquid sample solutions. Solid dosage forms, when tested intact, were assayed with a modified SOLIDprep Sampler unit. Some dosage forms were assayed directly from their pharmaceutical market containers via on-line dilution techniques. Some of the problems encountered are described and experimental design as well as methods of statistical analysis are discussed. The method reported has been recommended as an alternative to the official FDA manual procedure. In general, the automated hydroxylamine method compared well in accuracy and precision with the manual iodometric method. Manually diluted autoanalysis lacked the precision of other methods.

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Smart polymers in drug delivery: a perspective in pharmaceutical technology

Russian Journal of Biotherapy ◽

10.17650/1726-9784-2019-18-2-15-20 ◽

2019 ◽

Vol 18 (2) ◽

pp. 15-20

Author(s):

E. V. Blynskaya ◽

K. V. Alekseyev ◽

D. V. Yudina ◽

V. K. Alexseev ◽

S. V. Tishkov ◽

...

Keyword(s):

Dosage Forms ◽

Smart Polymers ◽

Solid Dosage Forms ◽

Solid Dosage ◽

Promising Tool ◽

Pharmaceutical Technology ◽

Polymer Properties ◽

Wide Range ◽

The World ◽

Polymer Research

Polymers have already been recognized as promising materials in many areas of life including pharmaceutical technology. A wide range of polymer properties such as providing controlled release of APIs, enhancing permeation and protection of APIs from mucosal enzymes is now successfully using worldwide in producing soft and solid dosage forms. It is now recognized that a significant portion of the polymer research ongoing in the world is related with a new group of polymer properties such as «shape memory system» and “self-folding”. This review focuses on “smart” – polymers properties that could be a promising tool in developing smart delivery systems.

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Evaluation of an Automated Dual-Channel Hydroxylamine Assay Procedure for Formulated Penicillin Products. II. Intact Solid Dosage Formulations

Journal of AOAC INTERNATIONAL ◽

10.1093/jaoac/57.6.1325 ◽

1974 ◽

Vol 57 (6) ◽

pp. 1325-1337

Author(s):

Jonathan R Lane

Keyword(s):

Drug Administration ◽

Automated System ◽

Assay Method ◽

Manual Method ◽

Solid Dosage ◽

Dual Channel ◽

Assay Procedure ◽

Wide Range ◽

Ampicillin Trihydrate

Abstract The dual-channel hydroxylamine method of Stevenson, Bechtel, and Coursen for the potency determination of formulated penicillins has been evaluated for use as an official Food and Drug Administration (FDA) alternative assay method for solid dosage formulations. A modified Technicon SOLIDprep Sampler I was used to assay a wide range of penicillin capsules and compressed tablets. In some instances, as many as 10 tablets/sample cup were tested. Results by this method and the official FDA manual method are compared. Some of the problems encountered in the analysis of ampicillin trihydrate capsule formulations and with compressed, film-coated tablets are also described. Based on the performance of the automated system and the data obtained, recommendations have been made to make the dual-channel hydroxylamine procedure an official FDA alternative assay technique for penicillin formulations.

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Validated UV Spectrophotometric Methods for the Estimation of Letrozole in Solid Dosage Forms

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2018.11.3.7 ◽

2018 ◽

Vol 11 (3) ◽

pp. 4129-4135

Author(s):

Suryakanta Swain ◽

Bikash Ranjan Jena ◽

Manohar Babu Sitty ◽

Debi Prasad Pradhan

Keyword(s):

Phosphate Buffer ◽

Uv Light ◽

Dosage Forms ◽

Solid Dosage Forms ◽

Pharmaceutical Dosage Forms ◽

Spectrophotometric Methods ◽

Solid Dosage ◽

Accuracy And Precision ◽

Pharmaceutical Industries ◽

Cost Efficient

The main intent of this research is to develop two new simple, novel, cost efficient and precise UV spectrophotometric methods for estimation of letrozole in pure and pharmaceutical dosage forms. For estimation of letrozole based on the measurement of UV light absorption, the spectras of letrozole were scanned efficiently and it exhibits maximum absorption wavelength (λmax) at 240nm for Method A and 245nm for Method B. The analysis was carried out against phosphate buffer pH 6.8 (Method A) and phosphate buffer pH 3.8 (Method B) respectively. The drug shows linear response commencing from 0.5-20 µg/mL for both methods A & B. The regression equation was found as Y= 0.099X + 0.079 (Method A) and Y= 0.1359x + 0.0048 (Method B), and correlation coefficient were 0.999 (Method A) and 0.9999 (Method B). The method validation was accomplished as per the regulation of ICH Q2R1 guidelines for linearity, accuracy, and precision studies. These reported methods have good reproducibility with percentage RSD less than one. These methods were extended towards the formulation and there was no interruption from excipients in the formulation. Hence, these proposed methods can be effectively employed for evaluation of letrozole in quality control as well as routine analysis work in pharmaceutical industries.

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