Near infrared spectroscopy as a field adapted technology for quality assessment of efavirenz and cotrimoxazole

Abstract

Background information: Near-infrared-spectroscopy (NIRS) combined with multivariate data analysis (MVA) represents the most recent and efficient technology in analytical chemistry. NIRS is simple, fast and suitable analytical method for quantitative and qualitative analysis.Although the common HPLC technique is accurate and precise with good reproducibility, excellent with respect to selectivity and sensitivity, however,it cannot be used for routine analysis because of its unique requirement which include cost, expertise and time requirement. Objective The main objective of this study was to utilize near infrared spectroscopy as a field adapted technology for quality assessment of selected drugs. Which specifically developed and validated a quantitative model for estimating amount of efavirenz in efavirenz tablets using NIR technology and a qualitative model for consistency assessment of cotrimoxazole tablets using hand held microPHAZIRTM. Methods For efavirenz, the active principle (efavirenz) was quantified with partial least-square algorithm and constructed by cross-validation. Ultra-Violet (UV) spectrophotometric procedure was used as a reference method. Different pre-processing methods were used for development of calibration models.For Zentrim®the development of the method involved trial and error methods which were proposed to reach to the ultimate threshold that would truly identify the product. The identification method used for expression of similarity was Spectral Matching. Results For efavirenz, the best calibration model was found when partial least square (PLS) was used as regression algorithm in association with Multiplicative Scattering Correction as pre-processing spectrum method. The model estimators were as follows; coefficient of determination (R²) was 0.9815, standard error of cross validation (SECV) was 2.0346 and a factor of 5. The chosen model correlated well with the prediction results in accordance with the Mahalabinos distance (M-distance) limits.Samples for Zentrim® were identified by comparison of their spectra with standard spectra in a reference library. An unknown sample was assumed to be positively identified if its correlation coefficient exceeded the established threshold (ρ = 0.9994648). Conclusion The developed NIR methods allows for the identification of zentrim® and also estimation of amount of efavirenz in tablet form without sample preparation. Thus, NIR-chemometric methods can be used for on-line, in line or at line monitoring of the manufacturing process and are helpful in achieving the goals of the process analytical technology.