Development of a New High-Performance Thin Layer Chromatographic Method for Quantitative Estimation of Lamivudine and Zidovudine in Combined Tablet Dosage Form Using Quality by Design Approach

Abstract

& The purpose of this study was to develop a new rapid and robust high-performance thin layer chromatographic (HPTLC) method for separation and quantitation of lamivudine and zidovudine in combined tablet dosage form using a quality by design approach. A Box-Behnken experimental design with response surface methodology was utilized to study the effects of chromatographic chamber saturation time, mobile phase migration distance, and mobile phase composition on R f value. The R f value was predicted for lamivudine and zidovudine in between 0.2 and 0.8 to optimize the chromatographic conditions based on the preliminary trials. The optimized chromatographic conditions were 21 min saturation time, 50 mm migration distance, and ethyl acetate:hexane:methanol:acetic acid (4:4:2:0.1 v=v=v=v) as a mobile phase. The optimized HPTLC method was validated according to International Conference on Harmonization (ICH) guideline Q2 (R1). The results of study clearly indicate that quality by design concept could be effectively applied to optimize HPTLC method with the minimum number of experimental runs. Developed HPTLC method was successfully applied for routine analysis of lamivudine and zidovudine in combine tablet dosage form.

Design, development and optimization of new high performance thin‐layer chromatography method for quantitation of Retapamulin in pharmaceutical formulation: Application of design of experiment

“…Based on previous experience and literature survey, precoated HPTLC plates with Silica Gel 60 F 254 on aluminum backing were selected and used as a stationary phase to develop and optimize HPTLC method for quantitative estimation of Retapamulin in cream formulation .…”

“…Linearity was predicted by estimating the regression coefficient (R 2 ), and the linear regression y‐intercept of the response versus concentration plot. Additionally, the residual plots for the sets of test data was generated .…”

“…System suitability test was carried out by analyzing the quality attributes in the data from the optimized HPTLC method, from six replicate injections of freshly prepared standard solution (100% concentration of analyte). The quality attributes monitored included R f value, injection precision, tailing factors, efficiency and peak purity of the analyte peaks .…”

“…Further, literature survey revealed no high‐performance thin layer chromatographic (HPTLC) method for quantitative estimation of Retapamulin in cream formulation. Currently, HPTLC is explored as a considerable alternative to HPLC for pharmaceutical analysis, because of its benefits like analysis of number of samples and reference simultaneously, repeated scanning of densitogram with same and/or different parameters, needed less amount of mobile phase, a smaller amount of toxic organic waste generation, etc . Conventional method development is normally based on trial and error strategy, by changing one chromatographic factor at a time and evaluating its effect on response which eventually results in costly, time consuming large number of development trails.…”

Design of Experiment Centered Multivariate Optimization Strategy for RP-HPLC Method to Quantitate Retapamulin in Topical Cream and Microemulsion

“…Additionally, it also enables to utilize necessary strategies to improve overall HPLC method performance. 6,[9][10][11]16 The current study elaborates on the utilization of the DoE approach for the optimization of a robust RP-HPLC method for the quantitation of RTPL in topical formulations (cream and microemulsions). Plackett-Burman design (PBD) was utilized to evaluate and screen chromatographic factors, namely pH of the mobile phase, % organic phase, flow rate, injection volume, column oven temperature and detection wavelength considering their significant impact on the peak retention time (T R ), peak tailing (T f ), and the number of plates (N) of RTPL.…”