First order derivative spectrophotometric method and high performance liquid chromatographic method were developed for the determination of Triprolidine and Pseudoephedrine Hydrochloride in tablet dosage form. In UV-Spectrophotometric method, estimation of Triprolidine and Pseudoephedrine Hydrochloride was carried out at the wavelength selected 246.20 nm and 263.50 nm for First order Derivative method. Calibration curves were linear in the range of 2-10 μg ml-1 for Triprolidine and 48-240 μg ml-1 for Pseudoephedrine Hydrochloride in derivative method. Correlation coefficient found to be close to 0.9950 for both the drugs. Accuracy for both the drugs was in the range of 99-101.5%. A simple liquid chromatographic assay has been developed for the determination of Triprolidine and Pseudoephedrine Hydrochloride. A C 18 (250×4.6 mm, 5 μm) column was used with a mobile phase consisting of Methanol: Water (80: 20 v/v) (pH adjusted to 3.0 with ortho phosphoric acid) at a flow rate of 1.0 ml min-1. Quantitation was achieved with UV detection at 246.20 nm based on the peak height ratios. Beer's law was obeyed in a concentration range of 5-25 µg ml-1 for Triprolidine and 120-600 µg ml-1 for Pseudoephedrine Hydrochloride and the regression line equation was derived with a correlation coefficient of 0.9999 and 0.9998 for Triprolidine and Pseudoephedrine Hydrochloride. The proposed procedures were successfully applied to the determination of Triprolidine and Pseudoephedrine Hydrochloride in bulk and tablet form, with high percentage of recovery, good accuracy and precision.

Introduction and Objectives: The present work involves development and validation of HPTLC method for simultaneous estimation of Cilnidipine and Metoprolol Succinate in their combined tablet dosage form. Method: In HPTLC method, Silica Gel G60 F254 TLC plate as the stationary phase and a mobile phase of Toluene: Chloroform: Methanol: Glacial acetic acid (45: 25: 25: 5 v/v/v/v) was used to resolve CIL and METO. CIL and METO were quantified at 231 nm. The proposed method weas validated according to International Conference on Harmonization. Result and Discussion: Two well-separated and sharp peak for CIL and METO were obtained at R f values of 0.70 ± 0.01 and 0.34 ± 0.005 respectively. The linearity range obtained for HPTLC method were 100-500 ng/spot and 500-2500 ng/spot for CIL and METO respectively. Conclusion: Method validation was found to be accurate, specific and precise.The developed method was successfully applied for estimation of CIL and METO in combined tablet formulation.

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Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

A revers phase liquid chromatographic technique has been developed for the separation and determination of candesartan cilexetil and amlodipine besylate using QbD (Quality by Design) approach. The present method was optimised by introducing experimental design approach to identify the chromatographic conditions for adequate separation quality and minimal analysis duration. The relation between independent variables and critical quality attributes is given by experimental design methodology. The separation was achieved on shim-pack solar C18 type column (250 mm × 4.6 mm, 5 µm) as stationary phase; acetonitrile: phosphate buffer pH 6.8 (82:18, v/v); 1.0 ml/min as flow rate; detection wavelength 235 nm. The chromatographic efficiency was investigated for the factorial effect of percentage organic phase and flow rate and finely optimized by employing factorial design experiment. The method was validated and was found to be accurate, precise and robust.