Simultaneous estimation of aspirin and omeprazole in laboratory sample by different UV spectrophotometric techniques

The aim of the present work is to develop simple, precise and economic UV- spectrophotometric methods for the simultaneous estimation of aspirin and omeprazole laboratory sample. The absorbance maxima (?max) for detection of aspirin and omeprazole were selected as 274 nm and 302 nm respectively for simultaneous equation method while wavelength range for detection of aspirin and omeprazole were selected as 270 nm - 276 nm and 300 nm - 305 nm respectively for area under curve method. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the ? max of one of the two components. From the overlay spectra of two drugs, it is evident that aspirin and omeprazole show an isoabsorptive point at 238.6 nm. Zero crossing first derivative spectrophotometry, where Aspirin showed zero crossing point at 301nm and Omeprazole showed zero crossing point at 274nm. Linearity for Aspirin was between 25- 125 ?g/mL and Omeprazole was 3-15 ?g/mL. These methods were successfully applied for estimation of Aspirin and Omeprazole in laboratory sample

Reverse Phase-High Performance Liquid Chromatography method development and validation for estimation of efavirenz by Quality by Design approach

Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. A very useful component of the QbD is the understanding of factors and their interaction effects by a desired set of experiments by using software (design expert 8). The present study describes the development of a comprehensive science and risk based HPLC method which is given by design expert 8 and subsequent validation for the analysis of Efavirenz active pharmaceutical ingredient (API) using a quality by design approach. An efficient experimental design based on systematic scouting of all four key components of the RP‐HPLC method (column, pH, mobile phase and flow rate) is presented. The described method was linear. R2=0.9998. The precision, ruggedness and robustness values were also within the prescribed limits (<1% for system precision and <2% for other parameters). Chromatographic peak purity results indicated the absence of co‐eluting peaks with the main peak of Efavirenz. The proposed method can be used for routine analysis of Efavirenz in quality control laboratories. Keywords: Quality by design, HPLC, Efavirenz, design expert 8

DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE THIN LAYERCHROMATOGRAPHIC METHOD FOR CIPROFLOXACIN BY QUALITY BY DESIGN APPROACH

Objective: The aim of this paper is to create a new, systematic high-performance thin-layer chromatography (HPTLC) method for ciprofloxacin that is based on quality by design (QbD). Methods: The mobile phase was chloroform: IPA: H2O: Formic Acid (2:7:0.5:0.5V/V), and the chromatographic separation was performed on aluminum-backed silica gel 60 F254 plates. Ciprofloxacin was detected using UV light at 278nm. In factor screening studies, a 3-factor 17-run standard 3-level factorial design was used, and a Box-Behnken design was used to optimize HPTLC experimental parameters for obtaining anticipated chromatographic conditions. The basic method parameters were tested to understand risk assessment. Three independent parameters, such as saturation time, band duration, and migration distance, were chosen and analyzed based on the risk assessment to see if these three parameters influenced the responses. For ciprofloxacin, the method produces a compact and well-resolved band at Rf = 0.40 0.02. In the linear regression analysis performed on ciprofloxacin, the regression coefficient was found to be r2 = 0.996. Results: According to the International Council on Harmonization (ICH) guidelines, it was validated for validation parameters such as accuracy, precision, robustness, the limit of detection, and the limit of quantification. The proposed method for ciprofloxacin determination was found to be straightforward, precise, reliable, stable, and sensitive. Conclusion: The QbD method produced a more robust method that can generate accurate, high-quality, and reliable data during the process, and it can be effectively used in the routine inspection of Ciprofloxacin in the tablets dosage form

An overview of technology transfer in industry

The objective of this review article is to study how technology is transferred in the pharmaceutical industry. This review article is to discuss the procedure for technology transfer process in pharmaceutical industry, importance of technology transfer, reasons for using technology transfer, methods of technology transfer, facets of technology transfer, list of institutes in Indian assisting in technology transfer, organization of technology transfer, function of technology transfer, steps involved in technology transfer, few case of involved in the technology transfer in the pharmaceutical industry and understand the aspects related with technology transfer