& A high performance liquid chromatographic (HPLC) method was developed for the simultaneous determination of paracetamol, (acetaminophen), caffeine, domperidone, ergotamine tartrate, propyphenazone, and drotaverine HCl. The chromatography was performed in the isocratic mode on a Hypersil C18 BDS column using a mobile phase consisting of 0.02 mole L À1 tetrabutylammonium bisulphate and methanol (100:45, v=v) at 50 C using UV detection at 210 nm. The method was validated by specificity, linearity, limit of detection, and limit of quantification, accuracy, and precision for the aforementioned drugs. The time required for a single analysis amounts to 14 min.

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Objective: Ranolazine (RZ), antianginal drug indicated for the treatment of chronic stable angina pectoris, was formulated into sustained-release matrix tablets and optimized to improve patient compliance and achieve controlled release over a certain period. Methods: Different formulations were prepared by wet- and melt-granulation techniques. Excipients at different ratios as Eudragit® L100-55, Methocel™ E5, Avicel® PH-101, and carnauba wax powder were used to develop a ternary polymeric matrix system for the controlled delivery of RZ. The prepared formulations were subjected to granulometric and characteristic studies. Comparative dissolution and release kinetic studies of the selected formulation and the reference product, Ranexa® extended-release film-coated tablets, Gilead Sciences, Inc., USA, were further carried out to ensure product similarity. Results: The optimum pH-dependent to pH-independent polymers ratio was 1:1.3 (w/w). Extragranular carnauba wax in a concentration of 32.50 mg/tablet (2.50 gm% w/w) was the key excipient in controlling drug release kinetics by forming waxy matrix granules which prevent rapid dissolution. Modulation of the microenvironmental pH using a potent alkalinizing agent was very effective for controlling drug release patterns in different dissolution media from pH 1.2–6.8. Conclusion: The release of RZ from the matrix tablets was controlled for a period of 24 h, and thereby expected to provide patient compliance with minimal side effects.

An HPLC method was developed for the simultaneous determination of residues of acetaminophen (paracetamol, PA), caffeine (CA), and drotaverine HCl (DH) on swabs collected from pharmaceutical manufacturing equipment surfaces. The challenge in cleaning validation is to develop analytical methods that are sensitive enough to detect traces of the active compounds remaining on the surface of pharmaceutical manufacturing equipment after cleaning. Chromatography was performed in the isocratic mode on a Hypersil C18 BDS column using the mobile phase 0.02 M tetrabutylammonium bisulfate-methanol (100 + 45, v/v) at 50°C with UV detection at 210 nm. The method was tested for specificity, linearity, LOD, LOQ, accuracy, and precision for determination of traces of the above-mentioned drugs. The time required for a single analysis was 12 min. The response was linear in the ranges of 6.900-52.100, 1.040-7.800, and 0.694-5.210 μg/mL for PA, CA, and DH, respectively.

Dissolution testing is an in vitro technique of great importance in formulation and development of pharmaceutical dosage forms, as it can be used as a substitute for in vivo studies under strictly defined and specified conditions. The main objective of the present study is to conduct the comparative dissolution studies of various brands of same dosage forms and treatment of obtained dissolution data by using ƒ2 to determine whether all the formulations used were equivalent or significantly different. Five different brands of drug containing paracetamol and caffeine from different manufacturers were used in the study, and dissolution testing in different dissolution media viz., water, 0.1 N HCl, phosphate buffer of pH 4.5 and phosphate buffer of pH 6.8 was conducted for 12 tablets from each brand for 60 min. by using dissolution testing apparatus USP type-II. Samples were withdrawn at 10 min. time interval and analyzed for drug content by using HPLC technique. Percent drug release at each time interval was calculated for tablets and the data obtained were treated with statistical technique to meet the FDA requirements for obtaining a waiver of bioavailability and bioequivalence studies.