The book has been designed primarily for analysts who are unfamiliar with the technique or have limited training and experience or have constraints in finding suitable HPLC method. The scope of this book has been restricted to practical application of HPLC for quantitative analysis of individual ingredients in wide spectrum of multi-component pharmaceutical dosage form with variant matrices. The book contains detailed procedures for analysis of 325 formulations under protocols along with relevant HPLC chromatograms to enable analysts to perform actual analysis without recourse to original reference cited under each protocol. This compilation is an attempt to circumvent time?consuming process of literature search for a suitable method.
With ever-increasing introduction of newer drug combinations, the analysts are often confronted with devising suitable validated methods of analysis for complex formulations.To help the analysts to access the required information, HPLC methods for about 300 fixed-dose formulations have been described in sequel to Vol. 1. Most of the methods included are claimed to have been validated by concerned authors. This should facilitate faster optimization of the method for actual laboratory use. The basic format of this volume is that of Volume 1.
Although the analysts have now acquired high level of expertise in routine application of this technique, however, developing a validated stability-indicating assay method as well as impurity profiling still remains a challenge. Since every analyst does not have access to latest publications on application of HPLC in Pharmaceutical Analysis and mentors being rare commodity, detailed analytical procedures for 452 formulations have been described in Volumes 3 and 4 in sequel to Volumes 1 and 2. Majority of the methods are reported to have been validated, still the analysts are advised to optimize the method under available laboratory facilities before adopting for regular use. All the four volumes in series on HPLC Quantitative Analysis of Pharmaceutical Formulations contain detailed analytical procedures for 1082 multi-component formulations primarily oriented to problem-solving and should help the analyst in develop in methods for newer formulations.
As a sequel to 4-volume series on HPLC titled Quantitative Analysis of Pharmaceutical Formulations containing detailed analytical procedures for 1082 fixed dose formulations published since 2001, the present four volumes (Volumes 5,6, 7, 8) have been compiled to update the literature in respect of HPLC methods of analysis for newly introduced formulations and for existing formulations as well. These 4 volumes provide analytical procedures for 906 fixed dose formulations. Each protocol includes sufficient details for analysts to reproduce the method. The methods included in the text are reported to have been validated by the reporting authors, for which relevant references have been cited. As usual, all the formulations classified as per their therapeutic use are arranged in 8 chapters. In addition to introduction, special feature of the series is a chapter on current validation procedure of HPLC method. Comprehensive details on trouble-shooting and practical tips as part of introduction should help the novice analysts to be better chromatographers.