International Journal of Pharmaceutical Chemistry and Analysis

1-6

Authors: Sachin L. Darkunde.

Quality by design (QbD) is an essential part of the modern advance to pharmaceutical quality. Quality has been given an importance by all regulatory body for pharmaceutical products. Quality means customer satisfaction in terms of service, products, and process. QbD is best key to build a quality in all pharmaceutical products. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceutical Analysis. Under this concepts of be throughout design and growth of product, it is important to identify desire product performance report Target product profile (TPP), Quality Target product profile (QTPP) and identify critical quality attributes (CQA). To recognize the impact of raw material critical material attributes (CAM), critical process parameters (CPP) on the CQAs and identification and control sources of changeability. USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submit chemistry, manufacturing, and controls (CMC) of NDA information representing application of QbD. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products. In the present review basic consideration of the QbD approach, its historical background, and regulatory needs are discussed. In detail explanation of elements of QbD i.e. method intent, design of experiment, and risk assessment is given. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals.

12-15

Authors: Mohib Khan.

The barks of Cinnamomum species found to contain essential oil, namely, Cinnamomum zeylanicum, C. camphora, C. tamala etcetra. The major component is Cinnamaldehyde. Essential oils from leaves of Lauraceae family have not yet been isolated. It was therefore thought to isolate essential oils from leaves of mentioned species and check presence of Cinnamaldehyde presence. It was found that Cinnaldehyde is found only in C. zeylanicum. At same time, as Cinnamaldehyde is a chief constituent present in Cinnamomum species; it was observed that Cinnamaldehyde has been derivatized to make Schiff’s bases for very few compounds. For example, Cinnamyl chitosan Schiff base was prepared by coupling chitosan with trans-Cinnamaldehyde -the mean component of cinnamon oil- under acidic conditions to form cinnamyl chitosan Schiff base. Therefore, it was further thought worthwhile to derivatise Cinnamldehyde with available Substituted amines available in the local market followed by physical characterization.

24-30

Authors: Mohammad Faizan S Deshmukh, Mohammad Mujeeb G Khan, Sandip D. Firke, Atul A. Shirkhedkar.

The proposed experiments explain simple, precise, specific and accurate UV spectrophotometry methods for the estimation of Aripiprazole in bulk and pharmaceutical formulation. Aripiprazole is a recent second generation atypical anti-psychotic drug used for the treatment of schizophrenia; four simple UV spectrophotometric methods were established for estimation of Aripiprazole, using double beam UV spectrophotometer (UV-2450, Shimadzu, Japan). Aripiprazole showed maximum absorbance (λ max) at 255 nm in methanolic HCl as a solvent. The calibration curve obeyed Beer-Lambert law in the concentration range of 5 -30 μg/mL. The % recovery was found to be in the range of 98 - 100 %. Precision value less than 2 in terms of % RSD indicates precise nature of developed methods. Validation of developed methods was carried out as per ICH guidelines. It was concluded that the results and statistical analysis amongst all four methods, AUC method is most simple, accurate, precise, and specific. All four methods can be used for routine analysis of Aripiprazole in bulk and pharmaceutical formulations.

39-42

Authors: N. Pramod, B. Mayuri.

Six novel pyridine containing azetidinones Azt 1-6 have been synthesized from Schiff base by treating Pyridine-4-carbaldehyde with Substituted aromatic amines each were taken equimolar concentration in presence of Glacial acetic acid as a catalyst using Grindstone technique. Further Schiff base add benzene, triethylamine and chloro acetyl chloride undergoes condensation followed by elimination reaction result into novel pyridine containing azetidinone derivatives. The newly synthesized derivatives were characterized by using spectroscopic methods (IR, 1H-NMR, MASS) and screened for selected anti-tubercular. In vitro anti-tubercular activity was performed using Micro plate Alamar Blue Assay (MABA) method. Among synthesized compounds Azt5 and azt6 showed more potent Anti TB activity than standards.