Najma Sultana

Simultaneous determination of glipizide and glimepride by Rp-Hplc in dosage formulations and in human serum

In this article, simple, liquid chromatographic method has been developed and validated for the determination of glipizide and glimepride in pharmaceutical formulations and in human serum. Chromatographic separation was carried out on a Nucleosil, C18 (10xa0μm, 25xa0×xa00.46xa0cm) column using the mobile phase 80:20 methanol:water with pH adjusted to 3.5 at a flow rate 1xa0mlxa0min−1. Peak intensity of the drugs was recorded at 230xa0nm with UV detection. The linearity of the method was studied over the concentration range of 0.15–5xa0μgxa0ml−1 (rxa0=xa00.9979) and 0.5–7.5xa0μgxa0ml−1 (rxa0=xa00.9988) for glipizide and glimepride, respectively. Detection and quantitation limits were found to be 20 and 46xa0ngxa0ml−1 and 70 and 141xa0ngxa0ml−1 for glipizide and glimepride, respectively. There was no significant interference of extra pharmacopeial ingredients and serum observed in the assay of these two drugs.

In vivo interaction studies of lisinopril with flurbiprofen and ibuprofen on carrageenan induced inflammation

D recent years, a sudden rise in interest for biosimilar molecules by large pharmaceuticals has been evident due to two major factors i.e., larger application of biosimilars strategy to control escalating health-care cost and impending expiration of patents of popular blockbusters. Analytical strategy adopted for these molecules, widely differs from that of small molecules, due to inherent variations in living systems involved during manufacturing process and large size of biomolecules. Considering these facts, regulators have also emphasized multidimensional (structural, cellular potency and similar clinical efficacy) approach for their market approvals.Analytical strategy adopted for qualification and quantitation of P-38 (Mol. Wt. 44 kDa) and mAb (Mol.Wt. 141 kDa) molecules, demonstrate a systematic approach towards such applications. Qualitative analysis included BioConfirm set-up and acquisition of Q1 spectrum for molecules. Mol. Wt. was confirmed through deconvoluted spectrum approach and had a good agreement with theoretical reference. Phosphogluconoylation (for P-38) and glycans presence (for mAb) were manifested in decisions for quantitation strategy.Selection of multiple qualifier ions (m/z 3156.6988 and 2736.0254) for single quantifier ion (m/z 3087.5633) was adopted for establishing linearity from 15 to 300 nanogram for P-38 (top-down approach). To demonstrate bottom-up approach; mAb was digested with LysC enzyme and extracts were analyzed to establish a linearity for range of 1 to 4000 microgram range using four quantifier ions (m/z 495.7553, 481.7634, 321.5115 and 288.1718). Above strategy provides a clear rational approach for discovery researches to begin and implement analytical instrumentation approach towards large biological therapeutics quantitation.B has facilitated the discovery of treatments for some of the most severe diseases known to man – worldwide. Now days in market, patients have access to many biotechnology drugs and vaccines, and medical science is working to grow that number every day. Biologic medicines are made in living organisms to produce proteins to treat various diseases, often by genetically modifying cell constructs or cell lines. When exclusive rights like patents for the first generation of approved biopharmaceuticals got either expired or are about to expire, the market is opening for generic versions, referred to as ‘biosimilars’ (European Union) or ‘follow-on protein products’ (United States). These are also called as similar biological medicines. Some of these are already on the market in Europe. Biosimilar medicine is similar to biological medicine which has already been authorized as the ‘biological reference medicine’. The active ingredients of both biosimilar medicine and biological medicine are similar and are used in general at the same dose to treat the same disease. Since biosimilar and biological reference medicines are similar but not identical, so the name, appearance and packaging of a biosimilar medicine differ to those of the biological reference medicine. A biosimilar manufacturer must commence pre-clinical and clinical studies so as to present pertinent data which establishes the quality, safety and efficacy of the product, as well as its similarity with the reference product. Biosimilars are still new and emerging market. Regulatory guidelines and standards are still being developed in some countries and they are constantly evolving as technology develops.In vivo interaction studies of ACE inhibitor (captopril) was carried out with commonly used NSAIDs (flurbiprofen and ibuprofen) in carrageenan induced inflammation (CII) rats to check the anti-inflammatory response of NSAIDs with captopril and alone. In our study the altered anti-inflammatory response was observe for NSAIDs when given simultaneously with captopril by comparing decrease in paw size (edema). Results were expressed in% reduction in paw size for every hour and were calculated for edema rate and percentage reduction using the formula, Edema rate (E%)=VT – VO/VO * 100 Where, VO=Rat’s hind paw volume before 1% Carrageenan administration and VT=Rat’s hind paw volume at t hour. Percentage reduction (R%)=E C – E T E C *100 Where, E C =Edema rate of control group and E T =Edema rate of test compound at t hour. Tukey’s post-hoc test was conducted to determine group means differences taking significant level p<0.05 and p<0.005 highly significant. It has been observed while comparing the anti-inflammatory response of commonly used NSAIDs alone and in combination with captopril that the activity of NSAIDs was enhanced by the addition of captopril as% reduction got higher and edema rate decreased. The synergistic effects of captopril with flurbiprofen and ibuprofen were observed on reduction of inflammation.

Simultaneous quantitation and monitoring of rosuvastatin with NSAIDs by liquid chromatography with UV detection

Overview and methods: A simple, accurate, and sensitive high-performance liquid chromatography-ultraviolet detection method was developed for simultaneous determination of rosuvastatin with co-administered nonsteroidal anti-inflammatory drugs (meloxicam, ibuprofen, and mefenamic acid) in active pharmaceutical ingredient (API), pharmaceutical formulations, and human serum. Isocratic separation was employed on prepacked Purospher Star C 18 (5 µm, 25 × 0.46 cm) columns at ambient temperature. The mobile phase consisted of methanol:water:acetonitrile (80:17.5:2.5 v/v), pH adjusted to 3.0 with o-phosphoric acid at 1 mL min -1 . The drugs in the eluant were monitored at isosbestic point of drugs at 230 nm. The method was compared by programming the detector adjusting the wavelength with time to match the individual analyte’s chromophore which enhanced sensitivity with linear range. Results: Linear behavior was observed between 0.1 and 2.5 µgmL –1 for rosuvastatin, 0.4 and 10 µgmL -1 for meloxicam, 0.25 and 6.25 µgmL -1 for ibuprofen, and 0.15 and 3.75 µgmL -1 for mefenamic acid, with r

SIMULTANEOUS DETERMINATION OF ENALAPRIL AND STATIN'S IN PHARMACEUTICAL FORMULATIONS BY RP-HPLC

ABSTRACT Simple, specific, economical and precise high performance liquid chromatographic method for the simultaneous determination of enalapril in presence of statins (rosuvastatin, atorvastatin and simvastatin) in API (active pharmaceutical ingredient) and formulation has been developed and validated. Chromatography was carried out at 25 ◦ C on a prepacked Purospher Star, C18 (5 mm, 250 x 4.6 mm) column with the isocratic mobile phase of acetonitrile: water (60:40 v/v) adjusting pH to 2.8. The UV detection was carried at 230 nm. The results obtained showed good agreement with the declared contents. Enalapril and statins separated in less than 10 mins with good resolution and minimal tailing and without interference of excepients. The method was linear in the range of 2.5–100 µgmL -1 for enalapril concentration with a correlation co-efficient 0.9995 and in the range 0.625–25µgmL -1 for statins concentrations having correlation co-efficient0.9990 (inter and intraday CV<2 .0%). The recovery was 99-102%. The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity and system suitability were met in all cases. The proposed method can be used for quantitative determination of enalapril and statins alone or in combination from API and formulations.

New Improved Quinlone Derivatives Against Infection

There had been a tremendous advancement in the quality and quantity of worldwide research production in the field of microbiology. Among various biomedical fields, microbiology has been the subject of extensive study due to the problems imposed on human health by countless infectious diseases known so far. Identification of infectious agents and to adapt measures for its eradication is considered a major tool for alleviating human from the burden of infections. Progressively it is important to modulate the structure of earlier marketed antibacterial agents to produce newer agents with superior antimicrobial profile.