Md. Faiyazuddin

Chromatographic analysis of trans and cis -Citral in lemongrass oil and in a topical phytonanocosmeceutical formulation, and validation of the method

For decades the antimicrobial potential of essential oils has been extensively studied, and aromatic oils are the subject of intensive research in the skin care industry for use in cosmetics [1–10]. Among the micro-organisms tested Propionibacterium acnes is highly susceptible to antimicrobial herb extracts and volatile oils [11–21]. Acne lesions develop in pilosebaceous units infected by P. acnes leading to blackheads, whiteheads, and development of pustules [1, 12–16, 18, 20, 21].

Aerodynamics and deposition effects of inhaled submicron drug aerosol in airway diseases.

Particle engineering is the prime focus to improve pulmonary drug targeting with the splendor of nanomedicines. In recent years, submicron particles have emerged as prettyful candidate for improved fludisation and deposition. For effective deposition, the particle size must be in the range of 0.5-5 μm. Inhalers design for the purpose of efficient delivery of powders to lungs is again a crucial task for pulmonary scientists. A huge number of DPI devices exist in the market, a significant number are awaiting FDA approval, some are under development and a large number have been patented or applied for patent. Even with superior design, the delivery competence is still deprived, mostly due to fluidisation problems which cause poor aerosol generation and deposition. Because of the cohesive nature and poor flow characteristics, they are difficult to redisperse upon aerosolization with breath. These problems are illustrious in aerosol research, much of which is vastly pertinent to pulmonary therapeutics. A technical review is presented here of advances that have been utilized in production of submicron drug particles, their in vitro/in vivo evaluations, aerosol effects and pulmonary fate of inhaled submicron powders.

Development and Validation of UHPLC/ESI-Q-TOF-MS Method for Terbutaline Estimations in Experimental Rodents: Stability Effects and Plasma Pharmacokinetics

An ultra high performance liquid chromatography-electrospray ionization-tandem mass spectrometric method (UHPLC/ESI-Q-TOF-MS) for the analysis of terbutaline (TB) in Wistar rat plasma has been developed and validated. The chromatographic separation was achieved on a Waters ACQUITY UPLC TM BEH C18 (100.0 mm� 2.1 mm; 1.7 � m) col- umn using isocratic mobile phase, consisting of 2 mM ammonium acetate and acetonitrile (90: 10; v/v), at a flow rate of 0.25 mL min -1 . The transitions occurred at m/z 226.19�152.12 for TB, and m/z 260.34�183.11 for the internal standard. The recovery of the analytes from Wistar rat plasma was optimized using liquid- liquid extraction technique (LLE) in ethyl acetate. The total run time was 3.0 min and the elution of TB occurred at 1.85±0.05 min. The linear dynamic range was established over the concentration range 1-1000 ng mL -1 (r 2 ; 0.9938±0.0005) for TB. The intra-assay and inter-assay accuracy in terms of % CV was in between 1.8-3.5. The lower limit of quantitation (LLOQ) for TB was 1.0 ng mL -1 . Analytes were stable under various conditions (in autosampler, during freeze-thaw, at room temperature, and under deep- freeze conditions). The developed method was successfully applied for pharmacokinetic profiling in rodents.

A STABILITY INDICATING HPTLC METHOD FOR THE ANALYSIS OF IRINOTECAN IN BULK DRUG AND MARKETED INJECTABLES

A simple, sensitive, precise, and accurate stability-indicating high performance thin-layer chromatographic method for analysis of irinotecan both as bulk drug and in marketed injectables has been developed and validated as per ICH guidelines. Chromatographic separation was achieved on LiChrospher aluminum plates precoated with silica gel 60F254 as stationary phase. The solvent system consisted of acetone–ethyl acetate–acetic acid 8.5:1.5:0.1 (v/v/v) and this system was found to give compact spots for irinotecan at RF value of 0.31 ± 0.02. Densitometric analysis was performed in the absorbance at 366 nm. The linear regression analysis for the calibration plots showed good linear relationship with r2 = 0.9973 ± 0.0013 in the concentration range of 50–500 ng/spot. The method was validated for precision, accuracy, recovery, and specificity. The % recovery (94.63–101.40%) and precision (≤4.30) were found to be satisfactory. Irinotecan was subjected to acid and alkali hydrolysis, oxidation, thermal, and ultraviolet radiation treatments. All the peaks of degradation products were well resolved from the standard drug with significantly different retention factor (RF) values. Developed method effectively separated out the drug from its degradation products and hence can be used as stability-indicating method as well as in routine analysis of irinotecan.

Bioanalytical approaches, bioavailability assessment, and bioequivalence study for waiver drugs: In vivo and in vitro perspective

Evidence of differences in bioavailability from different oral formulations of the same therapeutic agents had become obvious by the early 1960s. The consequent 40 years have produced the body of scientific belief, debate, and policy on the subject of bioequivalence. The motivating force behind many of these events has been the continued interest of the food and drug administration (FDA) to improve the manner in which these studies are conducted, the quality of the data generated from such studies, and the methods by which they are evaluated. Bioanalytical data used to support regulatory submission needs to be accurate and reproducible. In order to have confidence in the reliability of the data, it is important that the analytical method used to generate it is well characterized and fully validated. However, bioavailability assessment (BA) and bioequivalence (BE) studies are necessary in filing of the data towards the drug approval. This review article describes the methods for assessing bioavailability and bioequivalence; and bioanalytical approaches of pharmaceuticals in vivo and in vitro and also a waiver of BA/BE studies based on the biopharmaceutical classification (BCS) system.