Sample Blood samples were collected from 49 infertile women with endometriosis (study group); 38 age-matched women without endometriosis (control group I) but with infertility related to tubal defects, fibroids, polycystic ovaries, idiopathic infertility and pelvic inflammatory diseases diagnosed by laparoscopy and a further group of 21 age-matched women (control group II) with proven fertility and no evidence of endometriosis and other gynaecological disorders during laparoscopic sterilisation.Methods Concentrations of PEs were measured using gas chromatography.Main outcome measures Evaluation of PEs concentrations in women with endometriosis compared with women free from the disease.Results Women with endometriosis showed significantly higher concentrations of di-n-butyl phthalate (DnBP), butyl benzyl phthalate (BBP), di-n-octyl phthalate (DnOP) and diethyl hexyl .68] micrograms/ml). The correlation between the concentrations of PEs and different severity of endometriosis was strong and statistically significant at P < 0.05 for all four compounds (DnBP: r = +0.73, P < 0.0001; BBP: r = +0.78, P < 0.0001; DnOP: r = +0.57, P < 0.0001 and DEHP: r = +0.44, P < 0.0014).Conclusions This study suggests that PEs may have an aetiological association with endometriosis.

Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development. ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. Generic companies are implementing QbD approach in formulation development and even it is mandatory for USFDA perspective. As of now there is no specific requirements for AQbD (Analytical Quality by Design) and PAT in analytical development from all regulatory agencies. In this review, authors have discussed the implementation of QbD and AQbD simultaneously for API synthetic process and analytical methods development. AQbD key tools are identification of ATP (Analytical Target Profile), CQA (Critical Quality Attributes) with risk assessment, Method Optimization and Development with DoE, MODR (method operable design region), Control Strategy, AQbD Method Validation, and Continuous Method Monitoring (CMM). Simultaneous implementation of QbD activities in synthetic and analytical development will provide the highest quality product by minimizing the risks and even it is very good input for PAT approach.

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A rapid and simple high-performance thin layer chromatographic (HPTLC) method was developed for the simultaneous quantitative estimation of the biologically active triterpenoids beta-boswellic acid, 3-O-acetyl-beta-boswellic acid, 11-keto-beta-boswellic acid and 3-O-acetyl-11-keto-beta-boswellic acid from the gum resin of Boswellia serrata. The assay combines the isolation and separation of boswellic acid derivatives on silica gel 60F254-HPTLC plates with spot visualisation and scanning at 250 nm. Methanol was found to be the most appropriate solvent for the exhaustive extraction of boswellic acid derivatives.

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