DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC METHODS FOR SIMULTANEOUS ESTIMATION AND DISSOLUTION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORMS

The aim of this work was to develop and validate simple, accurate and precise spectroscopic methods (multicomponent, dual wavelength and simultaneous equations) for the simultaneous estimation and dissolution testing of ofloxacin and ornidazole tablet dosage forms. The medium of dissolution used was 900 ml of 0.01N HCl, using a paddle apparatus at a stirring rate of 50 rpm. The drug release was evaluated by developed and validated spectroscopic methods. Ofloxacin and ornidazole showed 293.4 and 319.6nm as λ max in 0.01N HCl. The methods were validated to meet requirements for a global regulatory filing. The validation included linearity, precision and accuracy. In addition, recovery studies and dissolution studies of three different tablets were compared and the results obtained show no significant difference among products.

SEC publishes important guidance on the Custody Rule, participating affiliate arrangements, robo-advisers, Form PF and certain compliance topics

Purpose To highlight guidance issued by the US Securities and Exchange Commission (SEC) for the benefit of investment advisers regarding certain obligations under the Investment Advisers Act of 1940 (Advisers Act) and the rules thereunder. Design/methodology/approach Summarizes recent guidance regarding issues related to several challenging Advisers Act requirements, including inadvertent custody and client account transfers under Advisers Act Rule 206(4)-2, the use of participating affiliate arrangements pursuant to the “Unibanco” no-action letters, unique considerations affecting automated advisers (i.e., “robo-advisers”), the top five most frequently identified compliance topics identified in examinations conducted by the SEC’s Office of Compliance Inspections and Examinations (OCIE), and recent guidance regarding the private fund regulatory filing Form PF. Findings This guidance may assist advisers in preparing for regulatory examinations and questions from institutional investors. While the recent guidance addresses important topics, the guidance also raises some practical questions. Originality/value Practical guidance from experienced securities and financial services lawyers.

An Examination of Management's Regulatory Filing Choices Surrounding Restatements

ABSTRACT A restatement suggests the existence of managerial errors and internal control weaknesses within the company. Disclosures of restatements highlight ineffective management and control systems such that management might act strategically in disclosing restatement and choose less transparent options. There are, however, external forces that likely encourage management to provide more transparent restatement disclosures, despite the fact that managerial ineffectiveness will be publicized. We examine the association between company and restatement characteristics and management's restatement filing choices to provide insight into external economic forces driving the choice. We document that more transparent filing is positively associated with the materiality of the restatement, an SEC investigation, the reporting of material internal control weaknesses, and leverage, and negatively associated with a CEO change. We also find that restatements filed via 8-Ks and via 10-K/As, after the SEC rule clarification in August 2004, are associated with significantly more negative market reactions than other restatements.

Internal Audit Assistance and External Audit Timeliness

SUMMARY Professional standards guide external auditors to consider the effect of the client's internal audit work and opportunities to utilize the direct assistance of the internal audit function when planning and conducting audits. We examine the effect of internal audit assistance on external audit timeliness via the extent of external audit delay. We hypothesize and find that internal audit assistance is negatively associated with external audit delay. We also document moderating relationships between internal audit assistance and other internal audit environment characteristics, such as the extent of internal control reliance, coordination with the external auditor, and the investment in internal audit quality. Overall, our findings have implications for firms and external auditors who are evaluating the role and use of internal audit functions. Namely, our findings suggest that internal audit assistance may not only result in audit cost savings, but also in greater audit efficiencies. These findings are particularly germane given the challenges faced by external auditors in the form of greater audit requirements, shorter regulatory filing deadlines, resource constraints, and audit fee pressures.

Validation of a dissolution method with RP-HPLC analysis for Perindopril erbumine and Indapamide combination tablet

A Dissolution method with high performance liquid chromatography (HPLC) analysis was validated for perindopril erbumine and indapamide in combination tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, linearity, accuracy, precision, range, robustness and solution stability studies. The dissolution method, which uses USP apparatus 1 with basket rotating at 100 rpm, 1000 ml of phosphate buffer pH 6.8 as the dissolution medium, and reversed-phased HPLC was carried out at 50?C on a 4.6mm?250mm 5?m cyano column that contained USP packing L1 with acetonitrile: buffer pH 2.8::40:60 (v/v), as mobile phase. UV detector was set at 225 nm. A method was found to be selective, linear, accurate and precise in the specified ranges. Intra-day and inter-day variability for method was <2% RSD. This method was successfully used for quantification of perindopril erbumine and indapamide combination tablet formulations.