Rajendra B. Patil

This presented work is based on application of two multivariate calibration methods for simultaneous UV-Visible spectrophotometric determination of active substances in combined pharmaceutical formulation contained of Tinidazole (TINI) and Norfloxacin (NFX). The methods used were Partial Least Square (PLS) and Principal Component Regression (PCR). The spectra of both NFX and TINI were recorded at concentrations within their linear range 2.0-12.0 μg/mL for NFX and 5.0-30.0 μg/mL for TINI. The 29 set of mixtures were used for calibration and 07 set of mixtures were used for validation in the wavelength range of 260 to 320 nm with the wavelength interval λ= 0.2 nm in methanol. The methods were validated as per International Conference on Harmonization Q2 (R1) (ICH) guidelines. These methods were successfully applied for determination of drugs in pharmaceutical formulation (tablet) with no interference of the excipients as indicated by the recovery study results. The proposed methods are simple, rapid and can be easily used as an alternative analysis tool in the quality control as well as in process control of drugs and formulation.

As per the current expectation USFDA, MHRA and other major Regulatory Authorities, especially with respect to the Data Integrity policies, the Sponsor has decided to implement e-BMR project by end of 2020. However considering the current state of our different Electronic Records, and the complexity of the e-BMR project, this project cannot be achieved directly. A multitude of different systems has to be converted to ‘Electronic Records’. A number of other Systems and Equipments, which has Electronic Records, works in isolation and don’t interact with others. The systems which are to be converted to ‘Electronic Records’ includes different logs, like ‘Area and Equipment Usage Logs’, ‘Calibration Logs’, ‘Weighing Balance Verification Logs’, ‘Temperature and Relative Humidity Logs’. All these logs are to be converted to electronic records, before the next stage i.e. Integrating all Equipments and Instruments to the Central Server. Only after these two major system, along with other standalone systems like Bar Code Enabled Dispensing and Intermediate Storage Records are Online, that the main project e-BMR can be implemented, as it will require data from all other systems. This project is aimed for the 'Development and Validation of Electronic Data Recording System, Integra table with all Other Systems to create Complete Electronic Documentation’. There are no computerized systems available in Market which can meets this requirement. So a new computerized systems was configured and validated, which will later be integrated with other systems so smooth flow of data between all systems.

A new simple, accurate, precise and selective stability indicating high performance thin layer chromatographic method has been developed and validated for estimation of Orlistat Tablet.T he mobile phase selected was Toluene: Methanol(8:2v/v) with UV detection at 211nm.The retention factor for Orlistat was found to be 0.60±0.02. The method was validated with respect to linearity, accuracy, precision and robustness as per the ICH guidelines. The drug were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in concentration range of 6000-36000 ng/band. The thermal method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean ± S.D) was found to be 99.30±1.10.The developed method can be used for checking the stability of  Orlistst in bulk drug and pharmaceutical dosage form.

The simple, accurate, precise, sensitive, specific and cost- effective UV-VIS Spectrophotometric method was developed for the estimation of acyclovir in bulk and pharmaceutical dosage form, used as an antiviral drug. The absorption maxima of the drug were found to be 252.6nm. in 0.1N H2SO4solvent. The method was validated as per the ICH Guidelines. A linear response was observed in the range of 2-10µg/ml with a regression coefficient of 0.999. The developed method was precise; the % RSD was found to be less than 2%. The LOD & LOQ were found to be 2.3 and 7.0µg/ml respectively. The standard drug was subjected to acidic, alkaline, oxidative, thermal & photolytic stress degradation conditions. The samples so generated were used for degradation studies using the stability indicating UV-Visible Spectrophotometric method. This method was used for the determination of Acyclovir in tablet and cream formulation without interferences of the excipients, this indicated specificity of method.