Thesis (Ph. D.)--Virginia Polytechnic Institute and State University, 1992. / Vita. Abstract. Includes bibliographical references (leaves 99-103). Also available via the Internet.

The evaluation of the potential to use Ultra Performance Liquid Chromatography (UPLC) for the simultaneous quantification of all the actives in a multi-active tablet is described in this work. Part of the evaluation was to ensure that the necessary regulatory requirements were adhered to by ascertaining that an analytical method is suitable for a specific purpose through analytical method validation for the specific multi-active tablet. The UPLC method was also tested for the analysis of similar products, namely tablet formulations that contain similar active ingredients in the same proportions but with an additional active ingredient. A method for the simultaneous determination of paracetamol, caffeine and codeine phosphate was developed using UPLC technology. The UPLC developed method was more efficient than the existing in-house HPLC method. The UPLC method was then validated in accordance to ICH and USP guidelines. The application of this UPLC method for the analysis of similar products containing paracetamol, caffeine, codeine phosphate and one extra active ingredient was very challenging. The low concentration of the additional component, differences in sample matrix and differences in formulations added to the challenges. The direct application for the analysis of products Y and Z was not successful; however the method could be used as a platform for further research. A cost comparison between the UPLC and HPLC methods showed the UPLC method to be more cost effective. Thus, while maintenance costs are higher for the UPLC instrument, column costs are comparable to HPLC columns, but solvent and waste disposal charges decrease considerably due to lower solvent use. The reduction in instrument time dramatically improves the cost effectiveness of UPLC over HPLC due to a concurrent reduction in analyst time requirement. The results of this study show that the analytical costs associated with the analysis of multi-active drugs using HPLC procedures can be reduced substantially by the CONFIDENTIAL INTELLECTUAL PROPERTY OF ASPEN PHARMACARE implementation of UPLC technology. The hypothesis that the enhanced chromatographic power of UPLC can be leveraged to provide faster analysis times hence increased product throughput rates, and lower operating costs for the analysis of multi-active drugs was accepted. These advantages were achieved whilst meeting all regulatory requirements for analytical methods as required by regulatory bodies.

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Thesis (Ph. D.)--University of Hawaii at Manoa, 1994. / Includes bibliographical references (leaves 86-90). / Microfiche. / xiii, 90 leaves, bound 29 cm

Diss. (sammanfattning) Uppsala : Uppsala universitet, 2005. / Härtill 6 uppsatser.

Thesis (M.S.)--Youngstown State University, 1998. / Includes bibliographical references (leaves 120-122).

Thesis (M.S.)--Youngstown State University, 1998. / Includes bibliographical references.

The development of the monograph of a commonly used Chinese medicine, Lini Semen, for the Hong Kong Chinese Materia Medica Standards (HKCMMS) was recorded. HKCMMS is a set of reliable and internationally recognized standards of Chinese medicine. The monograph of Lini Semen was proposed, endorsed, and under editorial phase for the publication of the 9th volume of HKCMMS. In the proposed HKCMMS monograph of Lini Semen, besides regular content such as macroscopic and microscopic identification, and TLC identification, a HPLC fingerprint method and two assay methods were developed. All methods were well-established and validated. TLC identification: Lini Semen n-hexane extract is identified on a HPTLC Silica gel RP-18 plate, with α-linolenic acid and linoleic acid as the markers. The developing system consisted of acetone, acetic acid and dichloromethane in the ratio of 5:4:2. The spraying reagent was 5% sulphuric acid - ethanol solution and the plate was observed under 366 nm. HPLC fingerprint: Fingerprint of Lini Semen was conducted on a HPLC system with a C8 column. Mobile phase consisted of (A) water and (B) acetonitrile and isopropanol (9:1). Six characteristic peaks, including α-linolenic acid and linoleic acid were detected under 210 nm. Assay: α-Linolenic acid and linoleic acid were detected from Lini Semen n-hexane extract under the same HPLC condition of the fingerprint of Lini Semen. The proposed total content of α-linolenic acid and linoleic acid was not less than 0.56%. Secoisolariciresinol diglucoside (SDG) was detected from hydrolysed Lini Semen extract by HPLC system with a C18 column. Mobile phase consisted of (A) water and (B) acetonitrile. The detection wavelength was 280 nm. The proposed content of SDG was not less than 0.81%. Conclusion: It is the first time to propose a HPLC fingerprint and introduce SDG as a assay marker of Lini Semen in a regional standard monograph. The established methods for TLC identification, HPLC fingerprint, assay of the total content of α-linolenic acid and linoleic acid, as well as assay for SDG were validated with in-house and inter-laboratory comparison to prove that the methods are reliable.